Author: Donald O. Beers
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…
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…
