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Key Acts & Statutes

Federal Food, Drug and Cosmetic Act

• 1938 FD&C Act: Federal Food, Drug and Cosmetic Act

• FD&C Act, As Amended Chapter V: Drugs and Devices SEC. 505. [21 USC 355] New Drugs

Public Health Service Act

• 1944 Public Health Service Act (PHS Act)

• 1997 – FDAMA (Food and Drug Administration Modernization Act) Introduction of BLA, amended PHS Act, 42 U.S.C 262(a), section 351(a)

Prescription Drug User Fee Act

• 1992 Prescription Drug User Fee Act (PDUFA)

• 1997 – PDUFA II 
  • expanded the goals to include activities related to the investigational phases of a new drug's development and it also added the goal of increasing FDA communications with industry and consumer groups.
• 2002 — PDUFA III : Enhancements to FDA review process
• 2007 — PDUFA IV