How is COVID-19 Affecting the FDA?


COVID-19

We are closely monitoring the news and information concerning the COVID-19 virus (coronavirus) as well as how FDA and the private sector are responding and reacting to events as they continue to unfold. Please rest assured that we have business continuity plans in place and are ready and prepared to implement these plans if and when it becomes necessary to ensure a smooth continuation of service. Our global team at ProPharma Group is fully mobilized and working remotely to help you overcome the challenges your team may be facing while responding to new business requirements prompted by COVID-19. Click here to learn more.

April 7, 2020 – FDA approved an ANDA for Hydroxychloroquine Sulfate Tablets USP, 200 mg. for the treatment of: (1) Uncomplicated malaria due to P. falciparum, P. malariae, P. ovale, and P. vivax. (2) Chronic discoid lupus erythematosus and systemic lupus erythematosus in adults and (3) Treatment of acute and chronic rheumatoid arthritis in adults. Side effects of hydroxychloroquine include irreversible retinal damage, cardiac effects (including cardiomyopathy and QT prolongation), worsening of psoriasis and porphyria, proximal myopathy and neuropathy, neuropsychiatric events, and hypoglycemia.

March 17, 2020 U.S. Public Health Service (USPHS) staff are being deployed as needed. While the staff is completing initial and needed work, response to meeting requests and other submissions may be delayed.

March 17, 2020 Face-to-Face meetings are converted into telecons, through at least April 15 and likely longer.

March 10, 2020 In recent communications with the FDA, the agency stated “this is being implemented across all Divisions in the Office of New Drugs (OND), I am not sure about the other offices within FDA, at this time we are changing all March face to face meetings to teleconferences and notifying any Sponsors for April face to face meetings that those may also be changed to a teleconference.” The Weinberg Group is not aware of any impact on review or submission timetables at this time.

April 16, 2020 – FDA provided an update on one potential treatment called convalescent plasma and is encouraging those who have recovered from COVID-19 to donate plasma to help others fight this disease. Read more here.

April 16, 2020 – The agency launched a new webpage to guide recovered COVID-19 patients to local blood or plasma collection centers to discuss their eligibility and potentially schedule an appointment to donate. The webpage also includes information for those interested in participating in the expanded access protocol, conducting clinical trials, or submitting single patient emergency investigational new drug applications. Read more here.

April 16, 2020 – FDA posted tips on Shopping for Food during the COVID-19 Pandemic – Information for Consumers. Read more here.

April 16, 2020 – In its Daily Roundup, FDA provided a diagnostics update to date – “During the COVID-19 pandemic, the FDA has worked with more than 315 test developers who have said they will be submitting emergency use authorizations (EUA) requests to FDA for COVID-19 tests.  To date, 37 emergency use authorizations have been issued for COVID-19 tests.  The FDA has been notified that more than 190 laboratories have begun testing under the policies set forth in our COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance.”

April 16, 2020 – FDA issued a news release: “Coronavirus (COVID-19) Update: FDA, Gates Foundation, UnitedHealth Group, Quantigen, and U.S. Cotton Collaborate to Address Testing Supply Needs.”  Read more here.

April 16, 2020 – FDA issued a statement “Coronavirus (COVID-19) Update: FDA Continues User-Fee Related Reviews Through COVID-19.” Read more here.

April 15, 2020 – FDA issued two warning letters to companies who distribute chloroquine phosphate products intended to treat disease in aquarium fish

  1. Fishman Chemical of North Carolina, LLC
  2. Dr. G’s Marine Aquaculture, Inc.

April 15, 2020 – FDA and FTC issued a warning letter to a seller of fraudulent COVID-19 products

  1. The Art Of Cure

April 14, 2020 –FDA issued a consumer update “How You Can Make a Difference During the Coronavirus Pandemic.” Read more here.

April 13, 2020 – In its Daily Roundup, FDA provided a diagnostics update to date – “During the COVID-19 pandemic, the FDA has worked with more than 300 test developers who have said they will be submitting emergency use authorizations (EUA) requests to FDA for tests that detect the virus.  To date, 34 emergency use authorizations have been issued for diagnostic tests.  The FDA has been notified that more than 180 laboratories have begun testing under the policies set forth in our COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance.”

April 13, 2020 –FDA added new information to the Q&A for Consumers: Hand Sanitizers and COVID-19 .  These new questions focus on unintentional ingestion of hand sanitizer by children, as there has been an increase in calls to Poison Control for unintentional ingestion of hand sanitizer during the COVID-19 pandemic. Read more here.

April 12, 2020 –FDA issued an EUA for the ASP STERRAD Sterilization Systems that has the potential to decontaminate approximately 4 million compatible N95 or N95-equivalent respirators per day in the U.S. for single-user reuse by health care workers in hospital settings. Read more here.

April 10, 2020 – In its Daily Roundup, FDA provided a diagnostics update to date: “During the COVID-19 pandemic, the FDA has worked with more than 300 test developers who have said they will be submitting emergency use authorizations (EUA) requests to FDA for tests that detect the virus.  To date, 33 emergency use authorizations have been issued for diagnostic tests.  The FDA has been notified that more than 170 laboratories have begun testing under the policies set forth in our COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance.”

April 10, 2020 – FDA issued a Letter to Stakeholders: Do Not Use Ivermectin Intended for Animals as Treatment for COVID-19 in Humans. Read more here.

April 10, 2020 – FDA issued an EUA for a blood purification system to treat patients 18 years of age or older with confirmed COVID-19 admitted to the intensive care unit with confirmed or imminent respiratory failure. Read more here.

April 9, 2020 – In its Daily Roundup, FDA provided a diagnostics update to date – “During the COVID-19 pandemic, the FDA has worked with more than 270 test developers who have said they will be submitting emergency use authorizations (EUA) requests to FDA for tests that detect the virus.  To date, 32 emergency use authorizations have been issued for diagnostic tests.  The FDA has been notified that more than 150 laboratories have begun testing under the policies set forth in our COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance.”

April 9, 2020 – The FDA and FTC issued a warning letter to two companies for selling fraudulent COVID-19 products:

  1. Earthley Wellness dba Modern Alternative Mama LLC
  2. Free Speech Systems LLC d.b.a. Infowars.com

April 9, 2020 – FDA updated information on its website pertaining to safety protections regarding the use of Fecal Microbiota for Transplantation (FMT), informing healthcare providers about screening donors for COVID-19 and exposure to and testing for SARS-CoV-2.  Read more here.

April 9, 2020 – FDA provided a constituent update – “FDA Issues Best Practices on Safe Food Handling and Employee Health in Retail Food Settings During COVID-19 Pandemic.Read more here.

April 8, 2020 – In its Daily Roundup FDA provided an update on diagnostics to date – “During the COVID-19 pandemic, the FDA has worked with more than 270 test developers who have said they will be submitting emergency use authorizations (EUA) requests to FDA for tests that detect the virus.  To date, 31 emergency use authorizations have been issued for diagnostic tests.  The FDA has been notified that more than 150 laboratories have begun testing under the policies set forth in our COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance.”

April 7, 2020 – The FDA and FTC issued additional warning letters to three seller of fraudulent COVID-19 products, including:

  1. Genesis II Church of Health and Healing
  2. Savvy Holistic Health dba Holistic Healthy Pet
  3. CBD Online Store

April 7, 2020 – FDA issued a statement regarding serological tests.  Read more here.

April 7, 2020 – FDA provided an update on diagnostics to date – “During the COVID-19 pandemic, the FDA has worked with more than 270 test developers who have said they will be submitting emergency use authorizations (EUA) requests to FDA for tests that detect the virus.  To date, 30 emergency use authorizations have been issued for diagnostic tests.  The FDA has been notified that more than 150 laboratories have begun testing under the policies set forth in our COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance.  The FDA also continues to keep its COVID-19 Diagnostics FAQ up to date.”

April 7, 2020 – FDA’s CDER provided updates to a number of COVID-19-related webpages.  Read more here.

April 6, 2020 – FDA’s CDRH updated webpage on medical devices and the COVID-19 (coronavirus) pandemic.  Read more here.

April 6, 2020 – FDA provided and update on diagnostics to date – “During the COVID-19 pandemic, the FDA has worked with more than 270 test developers who have said they will be submitting emergency use authorizations (EUA) requests to FDA for tests that detect the virus.  To date, 28 emergency use authorizations have been issued for diagnostic tests.  The FDA has been notified that more than 145 laboratories have begun testing under the policies set forth in our COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance.”

April 5, 2020 – FDA’s CDRH updated its Letter to Healthcare Providers: Surgical Mask and Gown Conservation Strategies.  Read more here.

April 5, 2020 – FDA’s CDRH updated webpage on N95 respirators and surgical masks (face masks).  Read more here.

April 5, 2020 – FDA’s CDRH updated FAQs on shortages of surgical masks and gowns. Read more here.

April 5, 2020 – FDA’s CDRH updated FAQs on 3D printing of medical devices, accessories, components, and parts during the COVID-19 pandemic. Read more here.

April 5, 2020 – FDA’s CDRH posted “FAQs on Shortages of Surgical Masks and Gowns.”  Read more here.

April 4, 2020 – FDA’s CDRH issued an updated Letter to Industry on COVID-19.  Read more here.

April 4, 2020 – FDA’s CDRH updated its webpage on protecting the health and safety of medical device manufacturing personnel during COVID-19. Read more here.

April 3, 2020 – FDA provided an update on diagnostics to date – “During the COVID-19 pandemic, the FDA has worked with more than 240 test developers who have said they will be submitting emergency use authorizations (EUA) requests to FDA for tests that detect the virus.  To date, 28 emergency use authorizations have been issued for diagnostic tests.  The FDA has been notified that more than 125 laboratories have begun testing under the policies set forth in our COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance.  Link to EUAs.”  Read more here.

April 3, 2020 – FDA further extended the comment period for the Laboratory Accreditation for Analyses of Foods proposed rule. Read more here.

April 3, 2020 – FDA issued a constituent update which announced that FDA will temporarily conduct remote importer inspections under the Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (FSVP) rule Due to COVID-19. Read more here.

April 3, 2020 – FDA announced that it is leading an effort, working collaboratively with government, industry and academic partners, to develop and implement a protocol that will provide convalescent plasma to patients in need across the country who may not have access to institutions with clinical trials in place.  Convalescent plasma has the potential to lessen the severity or shorten the length of illness caused by COVID-19. This collaboration, involving BARDA, the American Red Cross and the Mayo Clinic, will allow for a simplified process for health care providers that will help ensure patient safety while allowing for the collection of needed information about product efficacy. The FDA anticipates that the effort will be able to move thousands of units of plasma to patients who need them in the coming weeks.

April 3, 2020 – FDA coordinates national effort to develop blood-related therapies for COVID-19.  Read more here.

April 2, 2020 – FDA released a public service announcement on food safety and the food supply.  Read more here.

April 1, 2020 – FDA also issued a Constituent Update related to the published guidance entitled “Temporary Policy Regarding Nutrition Labeling of Standard Menu Items in Chain Restaurants and Similar Retail Food Establishments During the COVID-19 Public Health Emergency.”  Read more here.

April 1, 2020 – In response to the COVID-19 pandemic, the FDA—in collaboration with the Centers for Disease Control and Prevention (CDC), the Biodefense and Emerging Infections Research Resources Repository (BEI Resources) and the Institute for Genome Sciences at the University of Maryland and the National Center for Biotechnology Information (NCBI)—developed quality-controlled, reference sequence data for the SARS-CoV-2 reference strain for the United States.  Availability of traceable and quality-controlled data will help test developers and vaccine developers:

  • Expedite development of medical countermeasures.
  • Identify new or more stable targets for future tests.
  • Enable in silico confirmation of targets.
  • Support development of synthetic reference material.
  • Enable viral population/quasi species analysis.

Read more here.

March 31, 2020 – FDA provided an update on diagnostics available to date – “During the COVID-19 pandemic, the FDA has worked with more than 220 test developers who have said they will be submitting emergency use authorizations (EUA) requests to FDA for tests that detect the virus. On March 30, FDA issued two additional emergency use authorizations for COVID-19 diagnostics, for a total of 22 authorized tests. Additionally, the FDA has been notified that more than 110 laboratories have begun testing under the policies set forth in our COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance.”

March 31, 2020 – FDA posted information regarding shortages of hydroxychloroquine and chloroquine to its drug shortages web page due to a significant surge in demand.

March 31, 2020 – FDA announced the introduction of a new program to expedite the development of potentially safe and effective life-saving treatments.  The program is known as the Coronavirus Treatment Acceleration Program (CTAP). Read more here.

March 30, 2020 – FDA issued a press release regarding the ways that it is continuing to accelerate the development of novel therapies for COVID-19.  Read more here.

March 30, 2020 – FDA issued a statement to announce that it is  expediting the review of diagnostic tests to combat COVID-19. Read more here.

March 30, 2020 – FDA released a statement “FDA on Signing of the COVID-19 Emergency Relief Bill, Including Landmark Over-the-Counter Drug Reform and User Fee Legislation.”  Read more here.

March 30, 2020 – FDA provided an update on diagnostics available to date – “During the COVID-19 pandemic, the FDA has worked with more than 230 test developers who have said they will be submitting emergency use authorizations (EUA) requests to FDA for tests that detect the virus. To date, 20 emergency use authorizations have been issued for diagnostic tests, including Abbott Diagnostics Scarborough, Inc., ID NOW COVID-19, a rapid (13 minutes or less) test. Additionally, the FDA has been notified that more than 110 laboratories have begun testing under the policies set forth in our COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance.”

March 30, 2020 – FDA issued a consumer update on safely using hand sanitizer.  Read more here.

March 29, 2020 – FDA announced the addition of further PPE EUAs.  Read more here.

March 28, 2020 – FDA issued a statement announcing further steps it is taking to help mitigate supply interruptions of food and medical products. Read more here. 

March 27, 2020 – FDA’s CBER published a summary of its meeting that was held on March 18, 2020 regarding Data Requirements Supporting FIH Clinical Trials with SARS-CoV-2 Vaccines.  Read more here.

March 27, 2020 – FDA’s CBER issued a Letter to Sponsors, Applicants, and Regulated Entities on COVID-19 (see attached).  This includes information about the conversion of in-person meetings to teleconferences through April 30.

March 27, 2020 – FDA issued a letter to stakeholders about the imminent threat to the health of consumers who may take chloroquine phosphate products used to treat disease in aquarium fish, thinking the products are interchangeable with FDA-approved drugs (used to treat malaria and certain other conditions in humans) that are being studied as a COVID-19 treatment for humans.  Read more here.

March 27, 2020 – FDA issued an update for consumers regarding food safety and availability during the coronavirus pandemic.  Read more here.

March 26, 2020 – FDA entered into a Memorandum of Understanding with the Department of Veterans Affairs and the National Institutes of Health, National Institute of Allergy and Infectious Diseases (NIH/NIAID), and is working with America Makes, the National Additive Manufacturing Innovation Institute, to facilitate connections between patients and healthcare providers, local manufacturers with capabilities, and designs for needed medical products. This MOU provides a framework for collaboration intended to facilitate regulatory and basic science innovation with 3D printing technologies to respond to COVID-19.  FDA also issued FAQs on 3D Printing of Medical Devices During COVID-19.  Read more here.

March 25, 2020 – FDA published its “Daily Roundup” listing the news stories from the day.  Read more here.

March 25, 2020 – “The FDA added hydroxychloroquine sulfate to category 1 under the Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act. The FDA does not intend to object to registered outsourcing facilities using hydroxychloroquine (or chloroquine phosphate, which was already on category 1), to compound human drugs provided the drugs meet other conditions and requirements in the FD&C Act. Compounding is generally a practice in which a licensed pharmacist, a licensed physician, or, in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist, combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individual patient. The FDA is placing hydroxychloroquine sulfate on category 1 after it reviewed the nomination and determined there was sufficient information for the agency to evaluate the substance for outsourcing facilities to use in compounding. When FDA categorized hydroxychloroquine sulfate it did not change its approach, but we prioritized this substance due to the COVID-19 pandemic. There are currently no FDA approved therapeutics or drugs to treat, cure or prevent COVID-19; however, there are FDA-approved treatments that may help ease the symptoms of COVID-19. Additionally, state-licensed pharmacies and federal facilities that compound drugs under section 503A of the FD&C Act may compound drugs using hydroxychloroquine sulfate or chloroquine phosphate bulk drug substances because they are components of an FDA-approved drug, provide other requirements in the Act are met.”

March 24, 2020 – FDA published its “Daily Roundup” listing the news stories from the day. Read more here.

March 24, 2020 – FDA offers assurance about food safety and supply for people and animals during COVID-19.  Read more here.

March 24, 2020 – FDA takes action to increase U.S. supplies through instructions for PPE and device manufacturers. Read more here.

March 24, 2020 – FDA Helps Facilitate Veterinary Telemedicine During Pandemic. Read more here.

March 24, 2020 – FDA warns consumers to beware of fraudulent coronavirus tests, vaccines, and treatments. Read more here.

March 23, 2020 – FDA published its first “Daily Roundup” of the day’s news stories.  Read more here.

March 23, 2020 – FDA & EMA collaborate to facilitate SARS-CoV-2 vaccine development. Read more here.

March 23, 2020 – FDA adds additional in vitro diagnostics as an EUA, including: Simplexa COVID-19 Direct (DiaSorin Molecular LLC), ePlex SARS-CoV-2 Test (GenMark Diagnostics, Inc.), Primerdesign Ltd Covide-19 genesig Real-Time PCR assay (Primerdesign Ltd), Xpert Xpress SARS-CoV-2 test (Cepheid). Read more here.

March 22, 2020 – FDA provides update on patient access to certain REMS drugs during COVID-19 public health emergency. Read more here.

March 22, 2020 – FDA continues to facilitate access to crucial medical products, including ventilators. Read more here.

March 21, 2020 – FDA issues first emergency use authorization (EUA) for point of care diagnostic. Read more here.

March 20, 2020 – FDA alerts consumers about unauthorized fraudulent COVID-19 test kits. Read more here.

March 20, 2020 – FDA allows expanded use of devices to monitor patients’ vital signs remotely. Read more here.

March 19, 2020 – FDA continues to facilitate development of treatments. Read more here.

March 19, 2020 – FDA issues a statement regarding the importance of blood donations and discuss the measures being taken by donation centers to practice social distancing wherever possible. Read more here.

March 18, 2020 – FDA Focuses on Safety of Regulated Products While Scaling Back Domestic Inspections”.  Read more here.

March 16, 2020 – FDA updated the original policy issued on Feb. 29 on diagnostic testing for coronavirus (COVID-19) to provide guidance to laboratories and commercial manufacturers.  Read more here.

March 16, 2020 – FDA issued diagnostics Emergency Use Authorizations to Hologic and LabCorp. Read more here.

March 13, 2020 – FDA Issues Emergency Use Authorization to Thermo Fisher for its TaqPath COVID-19 Combo Kit. Read more here.

March 13, 2020 – FDA is giving flexibility to New York State Department of Health and FDA issues Emergency Use Authorization diagnostic. Read more here.

March 10, 2020 – FDA announced that most Foreign Inspections are being postponed through April, effective immediately. Inspections deemed mission-critical outside the U.S. will be considered on a case-by-case basis. Read more here.

April 16, 2020 – FDA posted an interview with Frank Yiannas, FDA’s Deputy Commissioner for Food Policy and Response. The topics he covers include food safety and food availability, as well as an update on implementation of the FDA Food Safety Modernization Act and plans to release a blueprint for the New Era of Smarter Food Safety initiative. Read more here.

April 16, 2020 – FDA issued “Guidance for Industry: Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Outsourcing Facilities During the COVID-19 Public Health Emergency.”  The purpose of this guidance is for the Agency to communicate its temporary policy for the compounding of certain human drug products for hospitalized patients by outsourcing facilities that have registered with FDA under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 353b). Read more here.

April 16, 2020 – FDA added content to the Question and Answer Appendix to the “Guidance for Industry, Investigators, and Institutional Review Boards: FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency.”  Per FDA, “The updated guidance includes new content on conducting remote clinician-reported outcome or performance outcome assessments; remote site monitoring; electronic common technical document requirements; investigational product administration by a local health care provider who is not a sub-investigator; and information for sponsors on who they should contact at the FDA regarding certain changes to ongoing trials. There is also updated information about obtaining informed consent from a patient who is unable to travel to the clinical trial site due to COVID-19 illness or travel restrictions, in situations where electronic informed consent is not an option.” Read more here.

April 16, 2020 – FDA issued a “Guidance for Industry and Food and Drug Administration Staff: Enforcement Policy for Telethermographic Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.”  The purpose of this Guidance is to provide a policy to help expand the availability of telethermographic systems used for body temperature measurements for triage use for the duration of the public health emergency declared by the Secretary of Health and Human Services (HHS) on January 31, 2020. Read more here.

April 16, 2020 – FDA’s CDRH issued new and updated EUAs.  Read more here.

April 14, 2020 – Given the anticipated increase in demand for chloroquine phosphate and hydroxychloroquine sulfate, the FDA is taking steps to ensure that adequate supply of these drug products is available for patients:

Read more here.

April 13, 2020 – FDA’s CDRH issues new and updated EUAs.

April 13, 2020 – FDA issued another ventilator EUA for B. Braun Space and Outlook Pumps.  This is the first infusion pump EUA. Read more here.

April 11, 2020 –FDA’s CDRH updated on FAQs on Diagnostic Testing for SARS-CoV-2, including:

  • What is the difference between the types of tests available for SARS-CoV-2?
  • Are antibody, or serology, tests used to diagnose SARS-CoV-2 infection?
  • If antibody tests are not used for diagnosis or exclusion of SARS-CoV-2 infection, what is their purpose?
  • Can I offer my SARS-CoV-2 antibody test kit in the US without an EUA?
  • I am developing a SARS-CoV-2 antibody test kit and want to pursue an EUA. Do I need to have all of my validation and documentation completed and submitted in an EUA request to FDA before engaging with the FDA?
  • I am developing a SARS-CoV-2 antibody test kit and want to pursue an EUA. If my validation is complete, can I notify FDA and begin testing while I prepare and submit an EUA?
  • I am developing a SARS-CoV-2 antibody test kit and want to pursue an EUA. Is there an EUA template for COVID-19 antibody tests?
  • What are the current recommendations regarding minimum testing for demonstrating performance of a new SARS-CoV-2 antibody assay?

April 10, 2020 – FDA’s CDRH issued update to FAQs on Shortages of Masks and Gowns. Read more here.

April 10, 2020 – FDA issued an “FDA Voices: A Perspective on the FDA’s COVID-19 Response by Mitch Zeller, Director of FDA’s Center for Tobacco Products.” Read more here.

April 10, 2020 – FDA issued Guidance for Industry: Temporary Policy Regarding Non-Standard PPE Practices for Sterile Compounding by Pharmacy Compounders not Registered as Outsourcing Facilities During the COVID-19 Public Health Emergency. Read more here.

April 10, 2020 – FDA issued an EUA to decontaminate compatible N95 or N95-equivalent respirators for reuse by health care workers in hospital settings. The FDA issued the EUA to STERIS Corporation for the STERIS V-PRO 1 Plus, maX and maX2 Low Temperature Sterilization Systems using the STERIS N95 Decontamination Cycle (non-lumen cycle), which uses vaporized hydrogen peroxide. This EUA will support decontamination of approximately 750,000 N95 respirators per day in the U.S.

April 9, 2020 –FDA issued “Guidance for Industry: Policy for the Temporary Use of Portable Cryogenic Containers Not in Compliance With 21 CFR 211.94(e)(1) For Oxygen and Nitrogen During the COVID-19 Public Health Emergency.”  Read more here.

April 8, 2020 – FDA’s Office for Human Research Protections (OHRP) issued a Guidance on COVID-19. Read more here.

April 8, 2020 – FDA issued a Guidance for Industry: Investigational COVID-19 Convalescent Plasma.  The purpose of this guidance is to provide recommendations to health care providers and investigators on the administration and study of investigational convalescent plasma collected from individuals who have recovered from COVID-19 (COVID-19 convalescent plasma) during the public health emergency.  Read more here.

April 7, 2020 – New and updated EUAs for diagnostics and ventilators. Read more here.

April 7, 2020 – FDA released the presentation and transcript from the April 1, 2020 Virtual Town Hall Series “Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests.” Read more here.

April 6, 2020 – FDA issued “Guidance for Industry and Food and Drug Administration Staff: Enforcement Policy for Remote Ophthalmic Assessment and Monitoring Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.”  The purpose is to provide a policy to help expand the capability of remote ophthalmic assessment and monitoring devices to facilitate patient care while reducing patient and healthcare provider contact and exposure to COVID-19 during this pandemic. Read more here.

April 6, 2020 – FDA issued “Guidance for Industry and Food and Drug Administration Staff: Enforcement Policy for Extracorporeal Membrane Oxygenation and Cardiopulmonary Bypass Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.” The purpose is to provide a policy to help expand the availability of devices used in extracorporeal membrane oxygenation (ECMO) therapy to address this public health emergency.  Read more here.

April 5, 2020 – FDA issued “Guidance for Industry and FDA Staff: Enforcement Policy for Infusion Pumps and Accessories During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.”  The purpose of this guidance is to provide a policy to help expand the availability and remote capabilities of infusion pumps and their accessories for health care professionals during the COVID-19 pandemic.  Read more here.

April 4, 2020 – FDA issued “Guidance for Industry and Food and Drug Administration Staff: Enforcement Policy for Clinical Electronic Thermometers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.”  Read more here.

April 3, 2020 – FDA issued a “Guidance for Industry: Temporary Policy Regarding Packaging and Labeling of Shell Eggs Sold by Retail Food Establishments During the COVID-19 Public Health Emergency.”  The purpose of this guidance is to provide temporary flexibility regarding certain packaging and labeling requirements for shell eggs sold in retail food establishments so that industry can meet the increased demand for shell eggs during the COVID-19 pandemic. Read more here.

April 3, 2020 – FDA’s Center for Veterinary Medicine (CVM) issued a Guidance “CVM GFI #270 – Guidance on the Conduct and Review of Studies to Support New Animal Drug Development during the COVID-19 Public Health Emergency.”  The purpose of this guidance is “to help minimize the potential impact of the COVID-19 pandemic on new animal drug development and to provide recommendations for sponsors conducting ongoing studies to support new animal drug development.”  Read more here.

April 3, 2020 – FDA issued a new EUA for non-NIOSH-approved respirators made in China, which makes KN95 respirators eligible for authorization if certain criteria are met, including evidence demonstrating that the respirator is authentic.  This is listed under PPE EUA. Read more here.

April 3, 2020 – Additional EUAs added for additional PPE.  Read more here.

April 3, 2020 – A number of updates were made to the FDA for diagnostics.  Some of the changes include:

  • I am having trouble obtaining viral transport media/universal transport media (VTM/UTM) and a flocked nasopharyngeal swab to collect and transport patient samples. Are there alternatives that I can use?
  • What happens if I do not have the instruments referenced in the authorization of the CDC’s EUA-authorized test?
  • When FDA authorizes under an EUA a SARS-CoV-2 test for use at the point of care, does that mean it is CLIA waived?
  • When tests are offered prior to or without an EUA under the FDA’s Policy for Diagnostic Tests for Coronavirus Diseease-2019, what is their CLIA categorization?

Read more here.

April 2, 2020 – FDA revised a “Guidance for Industry and Food and Drug Administration Staff: Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised) .”  The revision was to help expand the availability of general use face masks for the general public and respirators (including N95 and KN95) for health care professionals during this pandemic.  Read more here.

April 2, 2020 – Additional EUAs added for  additional in vitro diagnostic and additional high complexity molecular-based laboratory developed tests.  Read more here.

April 2, 2020 – FDA revised an immediately in effect guidance to provide a policy to help expand the availability of general use face masks for the general public and particulate filtering facepiece respirators (including N95 and KN95 respirators) for health care professionals during this pandemic. Read more here.

April 2, 2020 – FDA issued an “FDA Voices: Perspectives from FDA Leadership and Experts” titled FDA Commissioned Corps Officers on the Front Line of COVID-19 Response: Almost 400 FDA Commissioned Corps officers deployed to aid in response to the coronavirus public health emergency.  Read more here.

April 2, 2020 – FDA provided an update on diagnostics to date – “During the COVID-19 pandemic, the FDA has worked with more than 240 test developers who have said they will be submitting emergency use authorizations (EUA) requests to FDA for tests that detect the virus. To date, 25 emergency use authorizations have been issued for diagnostic tests. Notably, the FDA issued an emergency use authorization, on April 1, 2020, to Cellex Inc.’s qSARS-CoV-2 IgG/IgM Rapid Test which is the first serology test to date to receive authorization to test for the presence of coronavirus antibodies. Cellex’s labeling notes that test results from this serology test should not be used as the sole basis for diagnosis and can only aid in the diagnosis of patients in conjunction with a medical review of symptoms and results of other laboratory tests. Cellex’s test is also limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform moderate and high complexity tests.  The FDA has been notified that more than 125 laboratories have begun testing under the policies set forth in our COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance.”

April 2, 2020 – FDA issued a fourth guidance providing notice of alternatives to certain requirements regarding blood donor eligibility for the duration of the COVID-19 pandemic. Read more here.

April 2, 2020 – FDA issued a statement that it is revising recommendations in several guidances regarding blood donor eligibility.  Read more here.

April 1, 2020 – FDA and FTC issued three additional warning letters, including:

April 1, 2020 – FDA provided an update on diagnostics to date – “During the COVID-19 pandemic, the FDA has worked with more than 220 test developers who have said they will be submitting emergency use authorizations (EUA) requests to FDA for tests that detect the virus. To date, 23 emergency use authorizations have been issued for diagnostic tests. On March 31st FDA issued an EUA that authorizes eligible molecular-based laboratory developed tests, or LDTs, that are developed and used by a single CLIA high complexity laboratory. Under this EUA, FDA has authorized Yale New Haven Hospital’s SARS-CoV-2 PCR test. Additionally, the FDA has been notified that more than 110 laboratories have begun testing under the policies set forth in our COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance.”

April 1, 2020 –FDA released a Guidance Document “Temporary Policy Regarding Nutrition Labeling of Standard Menu Items in Chain Restaurants and Similar Retail Food Establishments During the COVID-19 Public Health Emergency.”  Read more here.

FDA also issued a Constituent Update related to the published guidance.  Read more here.

March 31, 2020 –  FDA and FTC issued a warning letter to NeuroXPF.  Read more here.

March 31, 2020 – FDA issued additional in vitro diagnostics EUAs.  Read more here.

March 30, 2020 – FAQs updated for New Information on Diagnostic Testing for SARS-CoV-2.  This includes the following questions:

  • When FDA authorizes a SARS-CoV-2 test for use at the point of care, does that mean it is CLIA waived?
  • I am developing a COVID-19 assay that is a modification of a previously EUA authorized COVID-19 assay. Do I need to start from scratch with my validation or can I validate my test with a bridging study?

March 30, 2020 – FDA and FTC issued additional warning letters to three companies for selling fraudulent products with claims to prevent, treat, mitigate, diagnose or cure COVID-19.

  1. Warning Letter to Halosense Inc.
  2. Warning Letter to Bioactive C60/FullerLifeC60 LLC
  3. Warning Letter to JRB Enterprise Group Inc. DBA Anti Aging Bed

March 30, 2020 – FDA issued a guidance to help expand the availability of surgical apparel for health care professionals, including gowns (togas), hoods, and surgeon’s and patient examination gloves during this public health emergency. Read more here.

March 30, 2020 – FDA amended its PPE EUA for the Battelle Decontamination System for use in decontaminating compatible N95 respirators for reuse by health care personnel during the COVID-19 pandemic. Read more here.

March 30, 2020 – FDA issued EUA to allow hydroxychloroquine sulfate and chloroquine phosphate products donated to the Strategic National Stockpile(SNS) to be distributed and used for certain hospitalized patients with COVID-19. Read more here.

March 29, 2020 – FDA issued a guidance that outlines an enforcement policy to help expand the availability and capability of sterilizers, disinfectant devices and air purifiers. Read more here.

March 29, 2020 – FDA issued updates to its FAQs on diagnostics testing for SARS-CoV-2. Read more here.

March 29, 2020 – FDA issued a “Guidance for Industry and Food and Drug Administration Staff: Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.” Read more here.

March 27, 2020 – MQSA Inspection Information Related to COVID-19. Read more here.

March 27, 2020 – FDA issued an updated guidance “Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic,” with an appendix adding questions and answers on this subject.  Read more here.

March 27, 2020 – FDA issued a “Guidance for Industry: Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act Guidance for Industry.” Read more here.

March 26, 2020 – FDA and FTC issued warning letters to two companies for selling unapproved products claiming to mitigate, prevent, treat, diagnose or cure COVID-19.

  1. Read more about the Warning Letter to Corona-cure.com here
  2. Read more about the Warning Letter to Carahealth here

March 26, 2020 – FDA provided an update on diagnostics to date – “During the COVID-19 pandemic, the FDA has worked with more than 220 test developers who have said they will be submitting emergency use authorizations (EUA) requests to FDA for tests that detect the virus. To date, 17 emergency use authorizations have been issued for diagnostic tests, including the AvellinoCoV2 test, which is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal and oropharyngeal swab specimens collected from individuals suspected of COVID-19 by their healthcare provider. Additionally, FDA has been notified that more than 100 laboratories have begun testing under the policies set forth in our COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance”

March 26, 2020 – The Agency issued a guidance document for industry and FDA staff entitled “Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency.” Read more here.

March 26, 2020 – FDA issued Q&A for Consumers regarding hand sanitizers and COVID-19. Read more here.

March 26, 2020 – FDA issued a guidance document for industry entitled “Temporary Policy Regarding Nutrition Labeling of Certain Packaged Food During the COVID-19 Public Health Emergency.” Read more here.

March 25, 2020 – FDA issued a final guidance document, entitled “Guidance for Industry and Food and Drug Administration Staff: Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency.”  Read more here.

March 24, 2020 – FDA issued another hand sanitizer related guidance document entitled “Guidance for Industry: Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19).” Read more here.

March 24, 2020 – FDA issued the first Emergency Use Authorization (EUA) for ventilators, ventilator tubing connectors, and ventilator accessories for use in healthcare settings to treat patients during the COVID-19 pandemic. Read more here.

March 24, 2020 – FDA issued an additional EUA for in vitro diagnostics for COVID-19 testing and for personal protective equipment.  Read more here.

March 24, 2020 – FDA updated the FAQs on diagnostic testing for SARS-Cov-2.  The most recent updates include:

  • If I do not have assay positive control materials, how can I obtain it?
  • I am developing a SARS-CoV-2 test and would like to request genomic RNA from SARS-related coronavirus 2, Isolate USA-WA1/2020 to validate my test. How may I do that?
  • I am having trouble obtaining viral transport media/universal transport media (VTM/UTM) and a flocked nasopharyngeal swab to collect and transport patient samples. Are there alternatives that I can use?

Read more here.

March 23, 2020 – FDA issued a MedWatch Safety Alert related to COVID-19 entitled “Fecal Microbiota for Transplantation: Safety Alert – Regarding Additional Safety Protections Pertaining to SARS-CoV-2 and COVID-19.” Read more here.

March 23, 2020 – FDA’s Center for Devices and Radiological Health (CDRH) issued a “Letter to Industry on COVID-19.” Read more here.

March 23, 2020 – FDA updates FAQs on diagnostic testing for SARS-CoV-2. Read more here.

March 20, 2020 – FDA issues a guidance document entitled Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic”. Read more here.

March 20, 2020 – FDA provides guidance on production of alcohol-based hand sanitizer to help boost supply, protect public health. Read more here.

March 19, 2020 – FDA advises patients on use of non-steroidal anti-inflammatory drugs (NSAIDs) for COVID-19. Read more here.

March 19, 2020 – FDA provides additional information on MQSA inspections related to COVID-19. Read more here.

March 18, 2020 – FDA issued a new “Guidance for Industry, Investigators, and Institutional Review Boards: FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic.” Read more here.

March 18, 2020 – Quest Diagnostics Infectious Disease, Inc. and Quidel Corp were added to the list of in vitro diagnostic emergency use authorizations. Read more here.

March 17, 2020 – FAQs on Diagnostic Testing for SARS-CoV-2. Read more here.

March 16, 2020 –Final Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff: Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency.  The purpose of this Guidance document is to provide a policy to help accelerate the availability of novel COVID-19 diagnostic tests developed by laboratories and commercial manufacturers during the public health emergency.  Read more here.

March 14, 2020 – Final Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency. The purpose of this Guidance document is to communicate the Agency’s policy for the temporary compounding of certain alcohol-based hand sanitizer products by pharmacists in State-licensed pharmacies or Federal facilities and registered outsourcing facilities for the duration of the publica health emergency. Read more here.

 

As the situation changes, we will provide updates letting you know if we implement our business continuity plan that touches any part of the service we provide for you. The Weinberg Group will not cease business operations, as we are able to work from remote locations, should it become necessary.

We recognize that you are also evaluating and taking steps to continue your business and protect your employees. We want to work with you to ensure the business we do together can continue without disruption. To this end, please keep us informed regarding any steps or business restrictions your company takes that will impact the way we work with you to ensure we make appropriate arrangements to account for this in our plans as well.