FDA News


FDA Announces Plans to Resume Domestic Inspections with new Risk Assessment System

On Friday, July 11th, Stephen Hahn, MD, Commissioner of the FDA, issued a Coronavirus (COVID-19) Update, announcing the Agency’s plans to resume “prioritized domestic inspections of FDA-regulated facilities and other associated activities.” In his announcement, Dr. Hahn states that FDA has been thoughtfully and deliberately planning the safest and most appropriate time for this to […] READ MORE...


FDA Issues Product-Specific Guidance Documents for Chloroquine Phosphate and Hydroxychloroquine Sulfate

On Tuesday, April 14th, FDA released two product-specific guidance documents for chloroquine phosphate tablets and hydroxychloroquine sulfate tablets, two drugs being investigated as potential treatments for COVID-19.  These guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). The guidance, entitled “Guidance on Hydroxychloroquine […] READ MORE...


FDA Requests all Zantac (Ranitidine) Products be Removed from the Market

On Wednesday, April 1, 2020, FDA issued a statement asking all companies to stop selling all forms of Zantac (ranitidine). Background On Friday, September 13, 2019, the FDA announced that “some ranitidine medicines, including some products commonly known as the brand-name drug Zantac, contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels.”  FDA also […] READ MORE...


Only 12% of Generic Drugs Reviewed Were Approved in the 1st Review Cycle, says GAO Report

On August 7th, the U.S. Government Accountability Office (GAO) published its report on generic drug applications.  In the report, GAO comments on the number of products approved on the first review cycle and makes several recommendations for FDA to improve these statistics. Over the past few years, FDA has made generic drug development a priority, […] READ MORE...


FDA Finalizes Guidance Concerning Premarket Tobacco Product Applications for E-Cigarettes

On, Tuesday, June 11th, 2019, the FDA issued a final guidance document entitled “Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems.”  The guidance was published less than a month after a federal judge ordered the Agency to speed up its review of vaping products and provides Sponsors with recommendations regarding the submission of premarket […] READ MORE...


Improvements Are Coming to the Inactive Ingredient Database (IID)

In a new draft guidance released by the FDA on July 11th, the promise was made for access to quantitative data on maximum daily exposure levels (MDEs) of excipients by October 1, 2020.  This will go a long way to making the IID more useful to sponsors trying to use it to qualify the safety […] READ MORE...


FDA Announces Update to Nonproprietary Naming Convention for Biosimilar Products

On Thursday, March 7th, FDA published a revised draft guidance, updating its nonproprietary naming convention for biological products licensed under section 351 of the Public Health Service Act (PHS Act).  According to a recent statement from Scott Gottlieb, MD, FDA Commissioner, the Agency no longer has intentions to modify the proper names of biological products […] READ MORE...


FDA Approves Nasal Spray to Treat Depression in Adults

Earlier this month, FDA announced the approval of Spravato (esketamine) nasal spray.  The product is to be used in conjunction with an oral antidepressant and is indicated for the treatment of depression in adults suffering from treatment-resistant depression. In a recent statement, Tiffany Farchione, M.D., acting director of the Division of Psychiatry Products in the […] READ MORE...


Draft Guidance: Requesting Nonbinding Feedback After an FDA Inspection of Your Medical Device Establishment

On Tuesday, February 19th, FDA published a draft guidance for medical device makers which identifies a process for companies to request nonbinding feedback on certain FDA Form 483 deficiencies noted during pre or postmarket inspections. Nonbinding Feedback In its draft guidance, FDA states that the intention of nonbinding feedback is to inform a Sponsor’s implementation […] READ MORE...


FDA Warns Health Care Providers About the Development of Cancer After Breast Implants

On Wednesday, February 6th, FDA issued a letter to health care providers to increase the awareness of an association between all breast implants and Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL). Reports received by the FDA indicate that patients with breast implants have a higher risk of developing the disease within the scar capsule adjacent […] READ MORE...