The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) 2020 – Is your OTC Drug Company Ready?
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 COVID-19. In addition to COVID-19 response efforts, the CARES Act includes new reforms intended to...
Food Facility Registration to Require DUNS Number and Renewal Season Approaches
Beginning October 1, 2020, FDA will require a unique facility identification (UFI) number when registering food production facilities. Right now FDA has only approved Data Universal Numbering Systems (DUNS) numbers for use as UFIs for food facility registration. DUNS...
FDA Announces New and Updated Drug and Medical Device User Fees
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 newly established Over-the-Counter Monograph User Fee Program (OMUFA), enacted as part of the...
USDA to Strengthen Organic Regulations
Recently U. S. Department of Agriculture (USDA)’s Agricultural Marketing Service (AMS) released a proposal to modify organic regulations. The proposed rule is intended to increase oversight of industry and institute more procedures for certifiers and...
DOJ Charges Manufacturer for Exporting Misbranded Masks
On June 5, 2020, the U.S. Department of Justice (DOJ) charged a Chinese manufacturer with exporting misbranded face masks, purported to be N95 respirators. The criminal complaint against King Year Printing and Packaging Co., Ltd. includes numerous allegations that it...
Shortages of PPE, Cloth Face Coverings, Disinfectants and Sanitation Supplies: New Recommendations by FDA and USDA
On May 22, 2020 the Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) announced their recommendations to deal with shortages during the COVID-19 pandemic for cloth face coverings, sanitation supplies, disinfectants and personal...
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...
New EUA Requirements for Serology Tests
On May 5th, the FDA added a very significant new requirement for commercial manufacturers of COVID-19 serology tests that are currently on FDA’s so-called “section IV.D list”: Submit a complete Emergency Use Authorization (EUA) Request to FDA before Monday, May 18,...
Warning about Face Mask Imports
Update 6/10/2020 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...
FDA Expands EUA to Include more Imported Disposable Face Masks
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...