Generic and Innovator Drugs

This Fifth Edition provides a complete reference to significant developments in FDA approval requirements, including extensive coverage of innovator drugs, the drug approval process & patent term extension. Plus, it includes the full text of relevant statutes, regulations, FDA guidelines, memoranda, correspondence, & more. This publication is an invaluable reference for drug company officials, regulatory affairs staffs, & legal counsel. This one-volume guide contains exhaustive discussions & analyses of all the major regulatory & legal actions from the 1938 FDCA grandfather clause through the latest ammendments to the Federal Food, Drug, & Cosmetic Act. Major topics covered include: FDA approval requirements Full new drug applications Abbreviated new drug applications & "paper" ANDAs Delaying approval of compettive products Public availability of NDA data The orphan drug amendments Debarment FDA fraud policy Accelerated approvals And more.