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 12, 2024 | Drugs, FDA and USDA Regulatory Update
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 | FDA and USDA Regulatory Update, Foods
The FDA has released a revised draft Introduction and Appendix 1 to the multi-chapter draft guidance for industry titled “Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry” (PCHF Draft Guidance). The changes...
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 6, 2024 | Drugs, FDA and USDA Regulatory Update
The FDA has issued a draft guidance document discussing Quality Considerations for Topical Ophthalmic Drug Products intended for topical use in and around the eye. This is an update to the draft guidance of the same name released in October 2023. The guidance...
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...
