Fee rates for OTC monograph drug facilities set by FDA.
FDA’s New OTC Drug Facility User Fees Announced
read more
FDA
The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) 2020 – Is your OTC Drug Company Ready?
UPDATE on Dec 30, 2020: FDA publishes new OTC drug user fees, read more here. Original Post Sept 9, 2020: On March 27, 2020, the President signed the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) to aid response efforts and ease the economic impact of...
FDA Announces New and Updated Drug and Medical Device User Fees
UPDATE 12/30/2020: FDA publishes new OTC drug user fees, read more here. Original Post 08/27/2020: FDA has officially announced the updated drug and medical device fees for the 2021 fiscal year (October 1, 2020 – September 30, 2021). This includes fees associated with...
Understanding the Difference Between FDA Enforcement Discretion and EUAs
The Emergency Use Authorization (EUA), together with the Food and Drug Administration’s (FDA’s) guidance on COVID-19-related enforcement discretion, were put in place so medical product manufacturers, importers, and distributors can bring certain devices and OTC drugs...
Bringing Face Masks to Market
Update 06/10/2020 On June 6, 2020, the FDA made several changes to EUAs for certain N95 respirators and Non-NIOSH-Approved Disposable Filtering Facepiece Respirators. FDA issued EUAs for products used to decontaminate certain N95 respirators for multiple-user reuse by...
GAO Study on FDA’s Seafood Import Alerts Released
U.S. Government Accountability Office (GAO) recently issued a report that reviewed the steps FDA takes when removing seafood products from import alert. Although FDA intends to conduct a certain amount of sampling or inspections as part of their decision to remove a...
New Year, New Compliance for the Nutrition Facts Panel
The Food and Drug Administration (FDA) started 2020 off strong; on January 1, 2020, FDA required compliance with new food and dietary supplement labeling regulations for manufacturers with ten million dollars in annual sales. Manufacturers with less than ten million...
FDA’s Notice of Intent to Inactivate Outdated Drug Listing Records: What Does This Mean?
On September 12, 2019, the U.S. Food and Drug Administration (FDA) will begin removinginactive drug listings from its drug listing database. In other words, inactive drug listings will no longer be “listed” with FDA, as required by law. A removed drug listing can be...
Annual Renewals for FDA-Registered Facilities
Between October 1 and December 31, certain Food and Drug Administration (FDA)-registered facilities must renew their registrations. Here are some things you need to know to ensure your renewal is completed on time. Medical device establishments: The process of paying...
FDA Issues First Warning Letter for Failure to Comply with FSVP
FDA issued their first Warning Letter to an importer for not complying with the Foreign Supplier Verification Program (FSVP) that was introduced 8 years ago with the Food Safety Modernization Act (FSMA). For this first Warning Letter, FDA selected a food importer that...
