Legal requirements for regulatory compliance
- Post-Approval Marketing Practices Regarding Drug Safety and Pharmacovigilance
- Marketing Unapproved New Drugs
- Legal Issues Surrounding the Importation of Foreign APIs
- Generic Drug Approval Process and Movement to Reform
- The Food and Drug Administration Modernization Act û FDAMA and Beyond
- FDAÆs Antibiotic Regulatory Scheme
- Pioneer and Generic Drugs: New Developments in 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
- Update on Quality Standards
- Obtaining Approval of a New Drug: Industry Perspective
- Obtaining Approval of a Generic Drug: Industry Perspective
- New Developments in the Approval and Marketing of Nonprescription or OTC Drugs
- Current Good Manufacturing Process and the Drug Approval Process
- The Influence of the USP on the Drug Approval Process
- Evolving Trends in U.S. Registration and Importation of Drug Products from Foreign Countries
- Marketing and Advertising Promotion: The Impact of Government Regulations
- CMC Post-Approval Regulatory Affairs: Constantly Managing Change
- CFR Part 11: Compliance and Beyond
Regulatory Requirements for Product Approvals and After
"examines a broad range of important aspects of FDA pharmaceutical regulation. The book interprets the regulatory requirements without getting bogged down in the regulations themselves.”
Journal of Clinical Research Best Practices
Journal of Clinical Research Best Practices
