Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations
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and Radiological HealthCenter for Biologics Evaluation and ResearchCenter for Drug Evaluation and Research Download the Draft Guidance Document Read the Federal Register Notice This draft guidance document...
Pet Supplement Industry on the Rise
Recent survey reports indicate that supplements for pets have reached US sales of nearly $3 billion, with dog and cat supplements comprising of approximately 75% and 20% of the total, respectively. The growing pet supplement market is aimed at pet health and wellness, particularly for issues like mobility, skin and coat health, and anxiety. Survey reports specifically indicate that hip and joint supplements are the most frequently type of supplement purchased.
Guidance for Industry: Action Levels for Lead in Processed Food Intended for Babies and Young Children
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...
FDA Issues Final Guidance on Analytical Testing for Industry Use in Tobacco Product Applications
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...