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...
Feb 6, 2024 | Cosmetics, Dietary Supplements, Drugs, FDA and USDA Regulatory Update, Foods, Medical Devices, Tobacco, Veterinary
FDA is issuing the draft guidance to describe the Agency’s current thinking regarding its use of remote regulatory assessments in order to increase industry’s understanding of RRAs and facilitate FDA’s process for conducting RRAs. FDA has used RRAs to conduct...
Feb 6, 2024 | FDA and USDA Regulatory Update, Medical Devices
The Food and Drug Administration (FDA) issued a final rule on January 31, 2024, to amend the medical device current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation defined in 21 CFR Part 820 to harmonize and modernize the...
Feb 1, 2024 | Issue of the Month, Medical Devices
The Importance of the Medical Device Single Audit Program (MDSAP) and EU MDR Lead Auditor Certifications By Kevin Walls, MBA, EAS Independent Consultant The Medical Device Single Audit Program (MDSAP) is a certification program many medical device manufacturers are...
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...
