Generic and Innovator Drugs: A Guide to Fda Approval Requirements

By Donald O. Beers

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.

• Format: Hardcover
• Language: English
• ISBN: 0735502811
• ISBN13: 9780735502819
• Release Date: December 1995
• Publisher: Aspen Law & Business
• Length: 1500 Pages
• Weight: 3.55 lbs.
• Dimensions: 9.5" x 2.8" x 6.5"