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...
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...
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...
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...
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...
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...
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...
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 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...
Last week the Food and Drug Administration (FDA) took a critical step towards enforcement of FSVP by creating Import Alert 99-41, "Detention Without Physical Examination of Human and Animal Foods Imported from Foreign Suppliers by Importers Who Are Not in Compliance...
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