The pharmaceutical regulatory process. (2005)

• Record Type: Book
• Further Information: Note: Edited by Ira R. Berry.
• Other Names: Berry, Ira R, 1942-
• Contents: Pharmaceutical Regulation Before and After the Food, Drug, and Cosmetic Act. New Drug Approval Process: Before and After 1962. FDA Regulation of Biological Products. Generic Drug Approval Process: Pre-1984 History Concerning Generic Drugs. Generic Drug Approval Process: Post 1984: Waxman-Hatch Reform. Food and Drug Administration Modernization Act. FDA's Antibiotic Regulatory Scheme: Then and Now. Pioneer and Generic Drugs: Balance Between Product Life Cycle Extension and Anti-Competitive Behavior. The Influence of the Prescription Drug User Fee Act on the Approval Process. Clinical Research Requirements for New Drug Applications. Active Pharmaceutical Ingredients. Obtaining Approval of a New Drug . Obtaining Approval of a Generic Drug. Current Good Manufacturing Practice and the Drug Approval Process. CMC Post-Approval Regulatory Affairs: Constantly Managing Change. The Influence of the USP on the Drug Approval Process. Ways and Means to U.S. Registration of Foreign Drugs. Common Technical Document-Quality (M4-Q): One Regulatory Participant's Perspective. 21 CFR Part 11: Compliance and Beyond. Marketing and Advertising Promotion: The Impact of Government Regulations. Approval and Marketing of Nonprescription or OTC Human Drugs.
• Publisher Details: New York : Marcel Dekker
• Publication Date: 2005
• Extent: 1 online resource (xiii, 711 pages), illustrations
• Subjects: 344.7304/233; Pharmacy -- Law and legislation -- United States; Drugs -- Law and legislation -- United States; LAW -- Administrative Law & Regulatory Practice; Drugs -- Law and legislation; Pharmacy -- Law and legislation; Pharmaceutical Preparations -- standards; Drug and Narcotic Control -- legislation & jurisprudence; Guideline Adherence -- legislation & jurisprudence; United States; Electronic books
• Languages: English
• ISBNs: 0203997042; 9780203997048; 1420030914; 9781420030914; 9780824754648; 0824754646
• Related ISBNs: 0824754646
• Notes: Note: Includes bibliographical references and index.; Note: Print version record.
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.