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Government Accountability Office (GAO)
Individual Patient Access to Investigational Drugs for Serious Diseases (Parallel Track Policy) (§ 561)
Prescription Drug Advertising: Manufacturer to Consumer
Switch of Prescription Drugs to Over-the-Counter Drugs
Overview of Important Developments in Medicaid and Prescription Drug Reimbursement
See U.S. Government Accountability Office (GAO)
General Motors Corporation v. Caldwell (1986)
generic drug labeling controversies
generic medications
dispensing, substitutions
Drug Price Competition and Patent Term Restoration Act (PTRA) of 1984
Generic Drug Enforcement Act (1992)
marketed unapproved drugs
pfizer V. shalala (1998) - Pfizer, Inc. V. Shalala
winn dixie of montgomery, inc. V. colburn (1998) - Winn Dixie of Montgomery, Inc. V. Colburn
antitrust litigation
Drug Efficacy Study Implementation (DESI)
Drug Price Competition and Patent Term Restoration Act (PTRA) of 1984
investigational drugs, access to
natural monopoly
section 505(b)(2) applications
“paper” new drug applications
See Good Manufacturing Practices (GMP)
Cosmetics
Kefauver-Harris Amendment of 1962
See Good Manufacturing Practices (GMP)
Explanation of Adulteration
Medical Device Amendments of 1976
Good Manufacturing Practices (GMP)
adulteration regulations
Law Made by Administrative Agencies
establishment of
Frost (1989)
Purpose of a Controlled Substance Prescription
Gordon v. Frost
grand jury
See generally recognized as safe and effective (GRASE)
New Drug Approval
See generally recognized as safe and effective (GRASE)
Defining "New Drug"
Over-the-Counter Drug Review
Griffiths v. Medical Board of California (2002)
guidance documents, overview
generally recognized as safe and effective (GRASE)
Generic Drug Enforcement Act (1992)
Gonzales v. Raich (2005)
government regulation, medicinal drugs
Griffin v. Phar-Mor, Inc. (1992)
Group Life and Health Insurance Co. v. Royal Drug Co. (1979)
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