On February 5, 2024, FDA issued a final guidance regarding reporting by drug establishments for listed drug and biological products manufactured, prepared, propagated, compounded, or processed for commercial distribution. The upshot is that drugs listed with FDA must...
Drugs
FDA Registration Renewal Season Opens Oct 1, 2023
Between October 1 and December 31, Food and Drug Administration (FDA)-registered facilities must renew their registrations. Our team has handled registration renewals for thousands of facilities. Here are some things you need to know to ensure your renewal is...
FDA Draft Guidance for Nonprescription Drugs Should Improve Labeling Consistency to Empower Consumer Choice
During the first full week of September, the Food & Drug Administration (FDA) released a draft guidance titled “Statement of Identity and Strength–Content and Format of Labeling for Human Nonprescription Drug Products.” This guidance outlines suggestions for...
CDER Issues Warning Letter on Drug Product Listing
On May 23, 2022, the Food and Drug Administration’s (FDA) Center for Drug Evaluation & Research (CDER) issued a public warning letter to Grimann S.A. de C.V. concerning contradictory information between their product labeling and their electronic drug product...
FDA Now Requiring Annual Report of Drug Product Manufacturing Volumes for 2020, 2021 and Beyond
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...
FDA’s New OTC Drug Facility User Fees Announced – OMUFA Fee Not Tied to Registration Renewal Season
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...
CDER Now Requiring Confirmation of U.S Agency for NDC Labeler Code Requests
Effective summer 2021, the Center for Drug Evaluation and Research (CDER) requires confirmation of U.S. Agency assignments for National Drug Code (NDC) drug labeler code requests submitted to the Food and Drug Administration (FDA). If the U.S. Agent has not been...
FDA’s New OTC Drug Facility User Fees Announced
Fee rates for OTC monograph drug facilities set by 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...