Generic and Innovator Drugs: A Guide to FDA Approval Requirements
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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