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