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Go inside the drug development and FDA regulatory process with today's most authoritative and popular reference on the topic. In its all-new 2008 edition, New Drug Development: A Regulatory Overview addresses the most cutting-edge developments redefining how new drugs are developed and regulated today, including:
How the FDA Amendments Act of 2007 will affect everything from drug reviews to postmarketing requirements.
How the CDER's efforts to integrate a "culture of drug safety" has affected the center's structure and its new drug review and approval processes.
How CDER's much-anticipated January 2008 transition to the eCTD as the "only valid esubmission format" will affect the FDA's drug submission and review process.
How the FDA and industry are already integrating pharmacogenomics, computer simulation, and other emerging technologies to inform key decisions.
Which drug development strategies are fulfilling their promise and offering optimal returns for industry, given the explosion of accelerated development/approval programs and pilot programs to speed the drug development and review process.
Find out why New Drug Development is pharma/biotech's "go-to" resource for regulatory, clinical, project management, training, and other drug development disciplines navigating the FDA's drug development approval processes.
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- Chapter 1. An Introduction to the U.S. New Drug Approval Process
- The FDA and the Food, Drug and Cosmetic Act
- New Drug Development and Approval: A Brief Overview of the Principal Steps
- Chapter 2. Nonclinical Drug Testing
- Trends in Nonclinical Testing
- FDA Guidance on Nonclinical Testing Requirements
- Types of Nonclinical Studies
- Pharmacology Studies
- Toxicity Studies
- Acute Toxicity Studies
- Subacute or Subchronic Studies
- Chronic Toxicity Testing
- Carcinogenicity Studies
- Special Toxicity Studies
- Reproductive Toxicity Studies
- Genotoxicity Studies
- Toxicokinetic Studies
- Nonclinical Testing and New Drug Excipients
- FDA Standards for Nonclinical Testing: Good Laboratory Practice (GLP)
- Chapter 3. The IND
- Types of INDs
- Investigator INDs
- Emergency Use INDs
- Treatment INDs
- Screening INDs
- The Applicability of the IND
- IND Content and Format Requirements
- Cover Sheet (Form FDA 1571)
- Table of Contents
- Introductory Statement
- General Investigational Plan
- Investigator's Brochure
- Clinical Protocols
- Chemistry, Manufacturing, and Controls Information
- Animal Pharmacology and Toxicology Information
- Previous Human Experience with the Investigational Drug
- Additional Information
- Pharmacogenomic Data and the IND
- Submitting the IND
- Maintaining/Updating the IND
- Protocol Amendments
- IND Safety Reports
- Annual Reports
- Information Amendments
- Chapter 4. CDER and the IND Review Process
- The FDA's Center for Drug Evaluation and Research
- Recent and Upcoming Changes in CDER Structure
- CDER's Review Divisions
- Division of Cardio-Renal Drug Products
- Division of Oncologic Drug Products
- Division of Neuropharmacological Drug Products
- Division of Metabolic and Endocrine Drug Products
- Division of Pulmonary and Allergy Drug Products
- Division of Anesthetic, Critical Care, and Addiction Drug Products
- Division of Reproductive and Urologic Drug Products
- Division of Medical Imaging and Radiopharmaceutical Drug Products
- Division of Gastrointestinal and Coagulation Drug Products
- Division of Anti-Infective Drug Products
- Division of Antiviral Drug Products
- Division of Special Pathogens and Immunologic Drug Products
- Division of Dermatologic and Dental Drug Products
- Division of Anti-Inflammatory, Analgesic, and Ophthalmic Drug Products
- Inside the FDA's Drug Review Divisions
- The IND Review Process
- Initial Processing of the IND
- The IND within the Review Division
- Pharmacology Review
- Chemistry Review
- Clinical Review
- Microbiology Review
- The 30-Day Review Clock
- The Clinical Hold
- IND Status
- Chapter 5. The Clinical Development of New Drugs
- Clinical Trials and the FDA's New "Critical Path" Initiative
- The FDA's Role in Clinical Trials
- The Structure of Clinical Trials
- Phase 1 Clinical Trials
- PK/PD and Phase 1 Trials
- Sponsor Information/Data Submissions During Clinical Trials
- Phase 2 Clinical Trials
- End-of-Phase 2 Meetings and Other FDA-Sponsor
- Communication During Clinical Trials
- Phase 3 Clinical Trials
- Pivotal Clinical Studies
- Standards for Pivotal Trials
- Determining Adequate Study Sizes
- Completing a Drug's Clinical Study
- Phase 4 Clinical Studies
- Chapter 6. Good Clinical Practices (GCP)
- Recent Developments in GCP
- Responsibilities of the Sponsor
- Selecting Investigators and Monitors
- Informing Investigators
- Review of Ongoing Investigations
- Recordkeeping and Record Retention
- Disposition of Unused Drug Supplies
- Sponsors and Data Safety Monitoring Boards
- Responsibilities of Investigators
- Control of the Product
- Recordkeeping and Record Retention
- Investigator Reports
- Assurance of IRB Review
- Handling of Controlled Substances
- The Institutional Review Board (IRB)
- Informed Consent
- Chapter 7. The New Drug Application (NDA)
- The History of the NDA
- NDA Content and Format Requirements
- The Common Technical Document/Electronic Common Technical Document
- The Fundamentals of NDA Submissions
- The Archival, Review, and Field Copies of the NDA
- Application Form
- The Index
- Labeling
- The New "Content of Labeling" Section
- The NDA Summary
- Chemistry Section
- The NDA's CMC Section and CDER's New Quality Assessment System
- Nonclinical Pharmacology and Toxicology Section
- Human Pharmacokinetics and Bioavailability Section
- Microbiology Section
- Clinical Data Section
- Safety Update Report Section
- Statistical Section
- Pediatric Use Section
- Case Report Tabulations Section
- Case Report Forms Section
- Patent Information
- Patent Certification
- Establishment Description
- Debarment Certification
- Field Copy Certification
- User Fee Cov
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