Jun 17, 2024 | Cosmetics, Dietary Supplements, Drugs, Foods, Issue of the Month
Product Claim Substantiation By Jay Ansell, EAS Independent Consultant Substantiating a product claim is required by U.S. law and can help brands avoid regulatory action or provide an effective defense in litigation. For example, in April 2023, the US Federal Trade...
May 29, 2024 | Drug and Device Corner, Drugs, Medical Devices
Final reminder that OMUFA facility user fees are due 1 June 2024. Per MoCRA, responsible persons are required to submit any serious adverse event reports to the FDA within 15 business days of receiving such report. Cosmetic labels are required to include a domestic...
Apr 25, 2024 | Drug and Device Corner, Drugs, Medical Devices
FDA announced the fiscal year 2024 OTC-Monograph Drug User Fee rates in the Federal Register Vol 89, No. 62 published 29 March 2024. These fees cover FDA’s FY2024 which runs from October 2023 through September 2024. The facility fees for FY 2024 are due on 3 June...
Apr 3, 2024 | Drugs, FDA and USDA Regulatory Update
FDA announced the fiscal year 2024 OTC-Monograph Drug User Fee rates in the Federal Register Vol 89, No. 62 published 29 March 2024. These fees cover FDA’s FY2024 which runs from October 2023 through September 2024. The facility fees for FY 2024 are due on 3 June...
Mar 28, 2024 | Drug and Device Corner, Drugs, Medical Devices
Reminder that CARES volume 2023 reports are due no later than 1 July 2024. Highlighted Guidance Documents Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide FDA is issuing this Technical Conformance Guide to assist registrants of drug...
Feb 26, 2024 | Drug and Device Corner, Drugs, Medical Devices
The FDA has issued a final Guidance Document to assist drug establishment registrants with understanding the CARES Act reporting requirements. Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act guidance offers very...
