title: Pharmaceutical provisions of the FDA Modernization Act of 1997: one year and counting.
abstract: The FDA Modernization Act of 1997 represents a notable public policy achievement that was conceived not out of crisis, but rather out of a shared commitment that the FDA can both protect patient health (by assuring drugs are safe and effective) and promote public health (by being given additional resources and new procedural efficiencies to accelerate the review of applications for new medicines). The FDA is conscientiously implementing this important new law, but there are areas where more work is required. On balance, the prospects are that this law will help usher in a much improved era for patients.
authors.affiliation: Amgen, One Amgen Center Drive, Thousand Oaks, CA 91320-1789, USA.
authors.forename: G M
authors.initials: GM
authors.lastname: Binder
mesh_terms: D001709:Biotechnology; D002648:Child; D017277:Drug Approval / Q000331:legislation & jurisprudence; D004348:Drug Labeling / Q000331:legislation & jurisprudence; D006801:Humans; D007880:Legislation, Drug; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*