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

Opioid REMS comment period reopened

The FDA reopened until October 19, 2010, the comment period of a public meeting held on May 27 and 28, 2009, to solicit input on developing Risk Evaluation and Mitigation Strategies (REMS) for certain opioid drugs.

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Topic Spotlight

Pharmacologic class descriptions guidance issued

A guidance to help applicants and the review staff in the FDA's Center for Drug Evaluation and Research determine when a drug belongs to an established pharmacologic class, as well as how to select the appropriate word, phrase, or term that describes the pharmacologic class for inclusion in approved prescription drug labeling was issued by the FDA.

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