New Drug
Approval Process
Accelerating Global Registrations
Fourth Edition
edited by Richard A. Guarino

Offering expert guidance on the clinical, regulatory, and statistical processes involved in the development of new pharmaceutical product applications for prescription and generic drugs, devices, and biologicals, New Drug Approval Process 4th Edition details the specific regulations, guidelines, and procedures that will advance and ensure approval of United States and global new product applications.

Alerts readers to clinical and regulatory tasks that require immediate attention and long-term follow-up in order to comply with the international acceptance of new product data.

Features:

• Provides new information based on the trial and error of its contributors, as well as practical advice on every aspect of global submissions
• Documents the essential details, requirements, and techniques necessary to submit new pharmaceutical applications globally
• Provides step-by-step direction on the content, assembly, and filing of U.S. and global submissions of investigational and new drug applications (INDs/NDAs), biological license applications (BLAs), abbreviated new drug applications (ANDAs), and supplemental new drug applications (SNDAs)
• Fully discusses the role and requirements of institutional review boards (IRBs), independent ethics committees (IECs), and informed consent (IC) along with the legal responsibilities of the sponsor, investigator, and monitor in the approval, implementation, and retention of the legal documents required for these processes
• Discusses the impact of the HIPAA Act on the handling of patient data and the use of existing databases
• Details critical aspects of the nonclinical, preclinical, and clinical development of products, as well as regulatory methods to accelerate these components in the process of new product development
• Details the requirements of the chemistry, manufacturing, and controls (CMC) section of INDs, NDAs and ANDAs
• Emphasizes the impact of all the components that comprise the Common Technical Document (CTD)

Contents

1. Regulatory Practices and Procedures of New Drug, Biologics and Device Development
   1. New Product Development Teams
   2. Nonclinical Drug Development: Pharmacology, Drug Metabolism, and Toxicology
   3. The Investigational New Drug Application (IND) and the Investigator's Brochure (IB)
   4. General Considerations of the New Drug Application
   5. The New Drug Application (NDA), Content and Format
   6. Abbreviated and Supplemental New Drug Applications (ANDAs and SNDAs)
   7. The Biologic License Application (BLA)
   8. Device Legislation and Application
   9. Orphan Drug Applications

2. Clinical Research Development
   10. Clinical Research Protocols
   11. Adverse Experiences, Adverse Reactions and Interactions of Drugs
   12. Biostatistics in Pharmaceutical Product Development Facts, Recommendations and Solutions
   13. Industry and FDA Liaison

3. Specific Aspects in the Process of New Product Submissions
   14. Chemistry, Manufacturing and Control (CMC) Requirements of the NDA and ANDA
   15. Data Presentation for FDA Submissions: Text and Tabular Exposition
   16. Preparing for FDA Inspections: Manufacturing Sites
   17. Technology Change - Advantages in the Pharmaceutical Industries
   18. The Common Technical Document (CTD) for the Registration of Pharmaceuticals for Human Use

4. Global Applications of Good Clinical Practices (GCPs)
   19. Obligations of the Investigator, Sponsor and Monitor
   20. Institutional Review Board (IRB)/Independent Ethics Committee (IEC) and Informed Consent (IC): Protecting Subjects throughout the Clinical Research Process
   21. Quality Assurance
   22. Managing Clinical Trials
   23. The European Union Directive on GCPs in Clinical Trials: Implications for Future Research
   24. HIPAA: A New Requirement to the Clinical Study Process

5. Effective and New Methodologies in Expediting New Product Approvals in the US and European Union
   25. Working with a CRO
   26. The Evolving SMO in the United States
   27. Accelerating New Product Approvals

Glossary
Appendix
Index

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