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QTc Information in Human Prescription Drug and Biological Product Labeling Guidance for Industry

This guidance provides recommendations and instructions to assist persons submitting cosmetic product facility registrations and product listings to FDA.

Procedural

This guidance provides recommendations for the design of pivotal clinical studies for devices intended to treat opioid use disorder.

Postmarketing Studies and Clinical Trials: Determining Good Cause for Noncompliance with Section 505(o)(3)(E)(ii) of the Federal Food, Drug, and Cosmetic Act

Inborn Errors of Metabolism That Use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development: Guidance for Industry

This draft guidance provides recommendations for information to include in regulatory submissions and design process considerations for these device types.

Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act

Psychedelic Drugs: Considerations for Clinical Investigations

Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, Drug, and Cosmetic Act