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Biosimilarity

This guidance describes FDA’s participation in the Voluntary Improvement Program (VIP). The VIP is a voluntary program intended to guide improvement to enhance the quality of devices.

Annual Status Report Information and Other Submissions for Postmarketing Requirements and Commitments: Using Forms FDA 3988 and FDA 3989 Guidance for Industry

Last week, the IRS announced “the start of a sweeping, historic effort to restore fairness in tax compliance by shifting more attention onto high-income earners, partnerships, large...

On August 29, 2023, the U.S. Fish and Wildlife Service (Service) published a final rule listing two distinct population segments (DPS)—the North Feather and Central Coast DPSs—of the...

Institutional Review Board (IRB) Review of Individual Patient Expanded Access Submissions for Investigational Drugs and Biological Products

Final Guidance for Industry and FDA Staff, Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development

This guidance provides clarification and updated information on the use of ISO 10993-1 to support PMAs, HDEs, IDE Applications, 510(k)s, and De Novo requests.

Administrative/Procedural Guidance

This guidance provides a policy to expand the availability of face masks and barrier face coverings during the COVID-19 pandemic.