Pharmaceutical Regulatory Process
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portes grátis
Pharmaceutical Regulatory Process
Berry, Ira R.; Martin, Robert P.
Taylor & Francis Ltd
06/2019
492
Mole
Inglês
9781138381285
15 a 20 dias
453
Descrição não disponível.
Preface. Contributors. PART I LEGAL REQUIREMENTS FOR REGULATORY COMPLIANCE. 1. Pharmaceutical Regulation Before and After the Food, Drug, and Cosmetic Act. 2. Modernizing the Food and Drug Administration. 3. The New Drug-Approval Process-Before and After 1962. 4. Generic Drug-Approval Process: Hatch-Waxman Update. 5. FDA Regulation of Biological Products. 6. FDA's Antibiotic Regulatory Scheme: Then and Now. 7. Generic Drugs in a Changing Intellectual Property Landscape. 8. The Influence of the Prescription Drug User Fee Act on the Approval Process. 9. Clinical Research Requirements for New Drug Applications. 10. Postapproval Marketing Practices Regarding Drug Safety and Pharmacovigilance. 11. Drugs Marketed Without FDA Approval. 12. FDA Regulation of Foreign Drug Imports: The Need for Improvement. PART II REGULATORY REQUIREMENTS FOR PRODUCT APPROVALS AND AFTER. 13. Active Pharmaceutical Ingredients. 14. Obtaining Approval of New Drug Applications and Abbreviated New Drug Applications from a Chemistry, Manufacturing, and Controls Perspective. 15. Obtaining Approval of a Generic Drug, Pre-1984 to the Present. 16. New Developments in the Approval and Marketing of Nonprescription or OTC Drugs. 17. Current Good Manufacturing Practice and the Drug Approval Process. 18. The Influence of the USP on the Drug Approval Process. 19. Ways,Means, and Evolving Trends in the U.S. Registration of Drug Products from Foreign Countries. 20. Impact of Government Regulation on Prescription Drug Marketing and Promotion. 21. CMC Postapproval Regulatory Affairs: Constantly Managing Change. 22. Living with 21 CFR Part 11 Compliance. Index.
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
OTC Drug;ANDA Applicant;Complete Response Letter;CTD Format;NDA Holder;ANDA Submission;Drug Products;CMC Section;CMC Information;CMC Submission;Drug Substance;Ich Guideline;Orange Book;Bioequivalence Studies;pre-IND Meeting;Pediatric Exclusivity;Patent Listing;DTC Television Advertisement;Foreign Drug;FDA Web Site;FDA's Compliance Policy Guide;Cosmetic Act;Drug Efficacy Study Implementation;National Academy;Current USP
Preface. Contributors. PART I LEGAL REQUIREMENTS FOR REGULATORY COMPLIANCE. 1. Pharmaceutical Regulation Before and After the Food, Drug, and Cosmetic Act. 2. Modernizing the Food and Drug Administration. 3. The New Drug-Approval Process-Before and After 1962. 4. Generic Drug-Approval Process: Hatch-Waxman Update. 5. FDA Regulation of Biological Products. 6. FDA's Antibiotic Regulatory Scheme: Then and Now. 7. Generic Drugs in a Changing Intellectual Property Landscape. 8. The Influence of the Prescription Drug User Fee Act on the Approval Process. 9. Clinical Research Requirements for New Drug Applications. 10. Postapproval Marketing Practices Regarding Drug Safety and Pharmacovigilance. 11. Drugs Marketed Without FDA Approval. 12. FDA Regulation of Foreign Drug Imports: The Need for Improvement. PART II REGULATORY REQUIREMENTS FOR PRODUCT APPROVALS AND AFTER. 13. Active Pharmaceutical Ingredients. 14. Obtaining Approval of New Drug Applications and Abbreviated New Drug Applications from a Chemistry, Manufacturing, and Controls Perspective. 15. Obtaining Approval of a Generic Drug, Pre-1984 to the Present. 16. New Developments in the Approval and Marketing of Nonprescription or OTC Drugs. 17. Current Good Manufacturing Practice and the Drug Approval Process. 18. The Influence of the USP on the Drug Approval Process. 19. Ways,Means, and Evolving Trends in the U.S. Registration of Drug Products from Foreign Countries. 20. Impact of Government Regulation on Prescription Drug Marketing and Promotion. 21. CMC Postapproval Regulatory Affairs: Constantly Managing Change. 22. Living with 21 CFR Part 11 Compliance. Index.
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
OTC Drug;ANDA Applicant;Complete Response Letter;CTD Format;NDA Holder;ANDA Submission;Drug Products;CMC Section;CMC Information;CMC Submission;Drug Substance;Ich Guideline;Orange Book;Bioequivalence Studies;pre-IND Meeting;Pediatric Exclusivity;Patent Listing;DTC Television Advertisement;Foreign Drug;FDA Web Site;FDA's Compliance Policy Guide;Cosmetic Act;Drug Efficacy Study Implementation;National Academy;Current USP
