Details

Subject(s)

• Drugs—Law and legislation—United States [Browse]
• Pharmaceutical industry—United States [Browse]
• Pharmaceutical policy—United States [Browse]
• United States Food and Drug Administration [Browse]

Related name

• Milne, Christopher-Paul [Browse]

Summary note

"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; and 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."--Publisher's description.

Bibliographic references

Includes bibliographical references.

Contents

• An introduction to the U.S. new drug approval process
• Nonclinical drug testing
• The IND
• CDER and the IND review process
• The clinical development of new drugs
• Good clinical practice (GCP)
• The new drug application (NDA)
• The NDA review process
• The FDA's priority review policy
• Advisory committees and the drug approval process
• Beyond approval: postmarketing drug manufacturer regulatory responsibilities
• The supplemental NDA and postapproval changes to marketed drugs
• The FDA's orphan drug development program
• CDER's bioresearch monitoring program
• Accelerated drug approval/expanded access programs
• The pediatric studies initiative.

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ISBN

• 9781882615858
• 1882615859

OCLC

192081375

RCP

C - S

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