Synopsis
The Fourth Edition 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. Plus, it includes the full text of relevant statutes, regulations, FDA guidelines, memoranda, correspondence, and more. This publication is an invaluable reference for drug company officials, regulatory affairs staffs, and legal counsel.
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 Drug Price Competition and Patent Term Restoration Act of 1984 (the Waxman-Hatch Act) to Debarment and the Generic Drug Enforcement Act of 1992.
Major topics covered include:
* FDA approval requirements
* Full new drug applications
* Abbreviated new drug applications and "paper" ANDAs
* Delaying approval of competitive products
* Public availability of NDA data
* The orphan drug amendments
* Debarment
* FDA fraud policy
* Accelerated approvals
* And more.
"synopsis" may belong to another edition of this title.
