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...
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...
Jan 29, 2024 | Drug and Device Corner, Drugs, Medical Devices, Uncategorized
Reminder that per the CARES Act of 2020, drug establishments are required to report NDC volumes annually. This applies to all facilities that manufacture, prepare, propagate, compound, or process drugs for commercial distribution in the United States. Although the FDA...
Dec 29, 2023 | Drug and Device Corner
With the requirement for Cosmetic Responsible Persons to report Serious Adverse Events to FDA beginning 29 December 2023, the agency has recommended using the current Form 3500A that is downloadable and fillable at MedWatch: The FDA Safety Information and Adverse...
Nov 29, 2023 | Drug and Device Corner, Drugs, Medical Devices
Reminder that 31 December is the deadline for submitting your drug registration renewal, medical device establishment registration renewal and drug listing certification. If NDC listing blanket certification is not submitted, each individual SPL file will need to be...
