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The objective of this guidance is to provide recommended standards to construct a single Adverse Event Report electronic message to transmit GL42 contents to all member regions and Product Problem Reports to FDA for veterinary medicinal products.

The U.S. Department of Labor seeks nominations for a labor representative position on the Federal Advisory Council on Occupational Safety and Health, aiming to enhance federal employee safety standards.

This is the draft guidance Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products

The Advisory Committee on Construction Safety and Health is set to meet on February 22, 2024, in Washington, discussing key construction safety issues, including the role of women in the industry and emerging technologies.

This is the guidance Human Gene Therapy Products Incorporating Human Genome Editing

Conducting Remote Regulatory Assessments Questions and Answers Draft Guidance for Industry

ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs

Generics Revision 1

This draft guidance provides recommendations on the procedures for applicants of abbreviated new drug applications (ANDAs) that wish to pursue a request for reconsideration within the review discipline at the division level or original signatory authority.

The guidance is intended to describe risk-based principles and mitigation strategies to assure the viral safety of biotechnology products, including the data necessary to submit in a marketing application.