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.

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.

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.

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.