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A federal judge has ordered Michael Cohen’s former attorney to explain where he came up with the court cases cited in Cohen’s request for early termination of supervised release, saying as far as the judge can tell “none of these cases exist.”

FDA encourages the early adoption of advanced manufacturing technologies (AMTs) that have the potential to benefit patients by improving manufacturing and supply dependability and optimizing development time of drug and biological products.

Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs Guidance for Industry

Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act

Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act

The purpose of this document is to provide guidance on the types of fees the FDA is authorized to collect under the Animal Generic Drug User Fee Act and how to request a waiver or a reduction of these fees.

The U.S. Food and Drug Administration (“FDA” or “we”) is issuing this Small Entity Compliance guide to help explain the actions that a small entity must take to comply with 21 CFR parts 130 and 131 after recent changes made in 2021 and 2022.

COVID-19: Developing Drugs and Biological Products for Treatment or Prevention

OSHAs National Advisory Committee on Occupational Safety and Health is set to meet on December 12 to discuss key issues in workplace safety, including mental health for healthcare workers and whistleblower protection, marking a significant event for occupational health professionals.

This guidance document provides the FDA’s recommendations on a risk-informed framework for credibility assessment of computational modeling and simulation (CM&S) used in medical device regulatory submissions.