Skyscape Web Viewer : Pharmacy Practice and the Law : Main Index

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generic medications 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 antitrust litigation Drug Efficacy Study Implementation (DESI) 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 dispensing, substitutions Drug Price Competition and Patent Term Restoration Act (PTRA) of 1984
See Good Manufacturing Practices (GMP) Explanation of Adulteration Medical Device Amendments of 1976 Cosmetics Kefauver-Harris Amendment of 1962 See Good Manufacturing Practices (GMP)
Gonzales v. Raich (2005)
Good Manufacturing Practices (GMP) establishment of adulteration regulations Law Made by Administrative Agencies
Frost (1989) Gordon v. Frost Purpose of a Controlled Substance Prescription
government regulation, medicinal drugs
See generally recognized as safe and effective (GRASE) Defining "New Drug" Over-the-Counter Drug Review New Drug Approval See generally recognized as safe and effective (GRASE)
Griffin v. Phar-Mor, Inc. (1992)
Group Life and Health Insurance Co. v. Royal Drug Co. (1979)
Government Accountability Office (GAO) Overview of Important Developments in Medicaid and Prescription Drug Reimbursement See U.S. 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
generally recognized as safe and effective (GRASE)
Generic Drug Enforcement Act (1992)
grand jury
Griffiths v. Medical Board of California (2002)
guidance documents, overview
General Motors Corporation v. Caldwell (1986)
generic drug labeling controversies