New Drug Development: A Regulatory Overview (8th Edition)

Published by: Parexel International

Published: Jan. 1, 2008 - 400 Pages

Table of Contents

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

Abstract

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.

By: Barnett Educational Services, in conjunction with Parexel International

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