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This guidance provides recommendations to industry on Master Files for new dietary ingredient notifications (NDINs).

Data Integrity for In Vivo Bioavailability and Bioequivalence Studies

This draft guidance provides animal study recommendations  to support a 510(k) submission for dental bone grafting material devices.

Guidance for Industry - Handling and Retention of Bioavailability BA and Bioequivalence BE Testing Samples, Generics

Annual Reportable Labeling Changes for New Drug Applications and Abbreviated New Drug Applications for Nonprescription Drug Products

This draft guidance identifies the cybersecurity information FDA considers to generally be necessary for cyber devices under section 524B of the FD&C Act.

Clincal / Medical

Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards

This guidance updates the Small Business Guidance including describing how FDA plans to implement the small business registration and listing fee waiver.

This guidance is intended to provide recommendations for collecting a representative sample for testing when fish and fishery products are subject to detention without physical examination (DWPE) due to the appearance of adulteration caused by pathogens.