Jan 9, 2025 | Drugs, FDA and USDA Regulatory Update
January 2025 Docket Number: FDA-2024-D-5374 Issued by: Center for Drug Evaluation and Research Center for Biologics Evaluation and Research Center for Veterinary Medicine Download the Draft Guidance Document Read the Federal Register Notice This guidance, when...
Jan 8, 2025 | FDA and USDA Regulatory Update, Medical Devices
Docket Number: FDA-2024-D-4488Issued by: Center for Devices and Radiological HealthCenter for Biologics Evaluation and ResearchCenter for Drug Evaluation and Research Download the Draft Guidance Document Read the Federal Register Notice This draft guidance document...
Jan 6, 2025 | FDA and USDA Regulatory Update, Foods
January 2025 Docket Number:FDA-2022-D-0278 Issued by: Human Foods Program Download the Final Guidance Document Read the Federal Register Notice FDA is committed to reducing lead in food. FDA’s Closer to Zero initiative is a science-based, iterative approach to...
Jan 6, 2025 | FDA and USDA Regulatory Update, Tobacco
Agency remains committed to providing resources to support application submissions January 6, 2025 Today, FDA issued “Validation and Verification of Analytical Testing Methods Used for Tobacco Products,” a final guidance providing tobacco manufacturers with...
Dec 27, 2024 | Cosmetics, FDA and USDA Regulatory Update
For Immediate Release: December 26, 2024 Today, the U.S. Food and Drug Administration (FDA) announced a proposed rule to establish and require standardized testing methods to detect and identify asbestos in talc-containing cosmetic products. This proposed rule, if...
Dec 24, 2024 | Drugs, FDA and USDA Regulatory Update
Today, the U.S. Food and Drug Administration issued a final rule establishing requirements for a nonprescription drug product with an additional condition for nonprescription use (ACNU). A nonprescription drug product with an ACNU is a drug product that could be...