Mar 12, 2024 | FDA and USDA Regulatory Update
FDA proposes to revise the existing regulations regarding the content and format of labeling for approved or conditionally approved new animal drugs to provide for a more comprehensive set of requirements in one location in the Code of the Federal Register (CFR)....
Mar 12, 2024 | FDA and USDA Regulatory Update, Foods
USDA today published its “Product of USA” final rule, which will allow voluntary “Product of USA” or “Made in the USA” label claims to be used on meat, poultry, and egg products only when they are derived from animals born, raised, slaughtered, and processed in the...
Mar 5, 2024 | Dietary Supplements, FDA and USDA Regulatory Update
The FDA recently announced final guidance for industry on “Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes.” This guidance is intended to help manufacturers and distributors of new dietary ingredients (NDIs) and dietary supplements...
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The FDA has released a revised draft Introduction and Appendix 1 to the multi-chapter draft guidance for industry titled “Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry” (PCHF Draft Guidance).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 | 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FDA is issuing the draft guidance to describe the Agency’s current thinking regarding its use of remote regulatory assessments in order to increase industry’s understanding of RRAs and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...