Generic and Innovator Drugs: A Guide to FDA Approval Requirements

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9780735576636: Generic and Innovator Drugs: A Guide to FDA Approval Requirements
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Completely updated, the new Seventh Edition of Generic and Innovator Drugs: A Guide to FDA Approval Requirements provides indispensable and practical insights into the FDA approval process.

You’ll find comprehensive coverage of:

  • Abbreviated new drug applications
  • 505(b)(2) new drug applications
  • Delaying approval of competing products
  • FDA approval of biologic drugs

No other book can cover the drug approval process as thoroughly, answering important questions like these:

  • What is required to extend the patent of an FDA-approved product?
  • When must a generic manufacturer notify the innovator manufacturer when submitting an ANDA or 505(b)(2) application?
  • When does the FDA delay approvals because of patent claims, and when does it ignore patents?
  • How can one challenge an FDA exclusivity decision?
  • When can a manufacturer safely sell a drug without prior FDA approval?
  • In what circumstances can a generic manufacturer obtain FDA permission to file an ANDA for a variant of an existing drug?
  • When will the FDA waive or reduce prescription drug user fees?
  • How can a company or an individual avoid debarment?
  • What steps are necessary to comply with the FDA’s Fraud Policy?
  • When and how can a drug company take advantage of FDA accelerated approval procedures?
  • What are the labeling requirements for exporting approved drugs?
  • How does the FDAAA of 2007 affect the drug and biologic approval requirements?

Generic and Innovator Drugs: A Guide to FDA Approval Requirements provides step by step guidance of the approval process and expert interpretation of:

  • The Hatch-Waxman Act (Drug Price Competition and Patent Restoration Act)
  • The Medicare Prescription Drug, Improvement, and Modernization Act
  • The Food and Drug Administration Modernization Act
  • The FDA Export Reform and Enhancement Act
  • The Food and Drug Administration Amendments Act of 2007
  • And more!

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Donald O. Beers
Published by Aspen Publishers (2008)
ISBN 10: 0735576637 ISBN 13: 9780735576636
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Irish Booksellers
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Book Description Aspen Publishers, 2008. Condition: New. book. Seller Inventory # M0735576637

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