Beginning July 24, 2022, consistent with 21 CFR 1.509(a), food importers will be required to ensure that their valid, 9-digit DUNS number is provided in the Entity Number field. As an Importer, what does this mean for you and your operation? Simply...
The Food and Drug Administration (FDA) is getting closer to requiring manufacturers and distributors of dietary supplements to list their products on a public FDA electronic database. On Tuesday, June 14, 2022, the US Senate Committee on Health, Education, Labor, and...
During the 2020 biennial renewal period, the U.S. Food & Drug Administration (FDA) began requiring food facilities to include a unique facility identifier (UFI) on their registration. The required UFI must be a DUNS number obtained through a third-party company,...
Update 06/03/2022: The next food facility registration renewal period begins October 1st and continues through December 31st. In preparation for this upcoming renewal season, FDA recently began validating the UFI status of existing registrations. The information...
In March of this year, the Center for Drug Evaluation and Research (CDER) branch of the Food and Drug Administration (FDA) implemented a new fee under the OTC Monograph User Fee Program (OMUFA). The fee was required of all facilities that produced OTC monograph drugs...
FDA has officially announced the updated medical device fees for the 2022 fiscal year (October 1, 2021 – September 30, 2022). All medical device manufacturers, importers, and distributors must pay an annual establishment registration fee to FDA. Please do not wait...
On Friday, July 23rd, a bipartisan group of Senators introduced legislation that, if enacted, would require the manufacturers of e-cigarettes, vaping products, and other forms of electronic nicotine delivery systems (ENDS) to pay annual user fees to the Food and Drug...
Fee rates for OTC monograph drug facilities set by FDA.
UPDATE 04/01/2021:On March 30, 2021, FDA announced that they are further extending the UFI deadline for Food Facilities until December 31, 2022. This is the second extension of this kind in response to industry concerns that food facilities were unable to obtain a UFI...
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...
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