FDC Act and Related Federal Laws

Full text of the federal Food, Drug, and Cosmetic Act and 54 related federal laws are provided, including recent legislation such as the FDA Modernization Act of 1997, Bioterrorism Act of 2002, the Animal Drug User Fee Act of 2003, the Pediatric Research Equity Act of 2003, the Project BioShield Act of 2004, and the Minor Use and Minor Species Animal Health Act of 2004. Select from the list of FDC Act and Related Federal Laws products below:

News Headlines

Topic Spotlight

Proprietary names usage for drug products, guidance

Recommendations to industry regarding the submission of a complete package that FDA intends to use to assess the safety of proposed proprietary names for drugs, including biological products, and other factors that, in association with the name, can contribute to medication errors are provided in a guidance published by the agency.

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Topic Spotlight

Regulatory site visit training program announced

Interested biologics facilities are invited to participate in the FDA's Center for Biologics Evaluation and Research (CBER) Regulatory Site Visit Training Program.

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