Aug 18, 2022 | Drugs, FDA and USDA Regulatory Update
The much anticipated Proposed Rule on Revising the National Drug Code Format was announced in the FR Vol 87, No. 141 Revising the National Drug Code. The FDA is proposing a 12 digit uniform NDC number to replace the current format of 10 digits, which when exhausted...
Aug 4, 2022 | FDA and USDA Regulatory Update
What You Need to Know EAS food facility registration clients will remember during the 2020 renewal period, the FDA had sent reminders of the requirement per 21 CFR 1.232(a)(2), of a unique facility identifier (UFI) for every location registered with the agency as a...
Jul 26, 2022 | FDA and USDA Regulatory Update
What You Need to Know FDA’s use of Remote Regulatory Assessments (RRA), originally developed during the COVID-19 health emergency, is being expanded. Announced in a Draft Guidance for Industry on July 22, 2022, FDA intends to use mandatory and voluntary RRAs as part...
Apr 28, 2022 | FDA and USDA Regulatory Update, Tobacco
As has long been anticipated, FDA, on April 28, 2022, announced a proposed rule that would prohibit menthol as a characterizing flavor in cigarettes, and all characterizing flavors other than tobacco in cigars. Once finalized and implemented, FDA enforcement will...
Sep 1, 2021 | FDA and USDA Regulatory Update, Foods
‘The Food Labeling Modernization Act’ (FLMA) was introduced this month in both houses of Congress by Representative Frank Pallone (D-NJ) and Senator Richard Blumenthal (D-CT), along with Representative Rosa DeLauro (D-CT) and Senators Ed Markey (D-MA) and Senator...
Oct 17, 2019 | EASeNews, FDA and USDA Regulatory Update
FDA has published a list of required records for foreign firms exporting food products for both animal and human consumption into the U.S. The Foreign Supplier Verification Program (FSVP), which is part of the Food Safety Modernization Act (FSMA), includes a number of...
