Generic and Innovator Drugs: A Guide to Fda Approval Requirements

Rating:
Summary: Generic and Innovator Drugs
Review: Generic and Innovator Drugs provides a complete reference to significant developments in FDA approval requirements, including extensive coverage of innovator drugs, the drug approval process and patent term extension.

The Fifth Edition includes expanded coverage of relevant issues, including:

A chapter on FDA regulation of biologic drugs
An explanation of the interpretation by the FDA and the courts of the market exclusivity provisions FDA administers
An explanation of the new user fee legislation and FDA commitments in response to that legislation
A chapter reflecting new FDA requirements on drug exports
Plus, the full text of relevant statutes, regulations, FDA guidelines, memoranda, correspondence, and more.
This one-volume guide contains exhaustive discussions and analyses of all the major regulatory and legal actions from the 1938 FDCA grandfather clause through the latest amendments to the Federal Food, Drug, and Cosmetic Act.
Generic and Innovator Drugs is an invaluable reference for drug company officials, regulatory affairs staffs, and legal counsel.

Table of Contents

FDA Approval Requirements
Full New Drug Applications
Abbreviated New Drug Applications and "Paper NDAs"
Delaying Approval of Competitive Products
Public Availability of NDA Data
Potential for Government Compensation for Innovators
The Orphan Drug Amendments
Debarment
FDA Fraud Policy
Accelerated Approvals
Export and Import Requirements
Prescription Drug User Fees

Rating:
Summary: Very handy reference
Review: This book makes complicated issues and statutes easier to understand. The book clarifies, using case citations, the FDA statutes. A very handy resource.