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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 application of the approval process, and expert interpretation and guidance on:
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
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