Proton Pump Inhibitors - CME Conferences
Proton Pump Inhibitors - CME Conferences Proton Pump Inhibitors - CME Conferences
6 th Annual Primary Care Spring Conference Thursday, April 12, 2012 Exclusivity Incentives FDA • NCE protection - 5 years • New salt or ester - 3 years • New use or dosage form - 3 years • Orphan drug status – 7 years Center for Drug Evaluation and Research Generic Incentives FDA • All approved products eligible for generic competition • Eliminated requirement for duplicative clinical trials • Created a regulatory process for faster approval of generic drugs Center for Drug Evaluation and Research Wayne Weart, Pharm D Cost Effective Rx
6 th Annual Primary Care Spring Conference Thursday, April 12, 2012 FDA Definition of a Generic Drug A drug product that is comparable to a brand/reference listed drug product in dosage form, strength, route of administration, quality and performance characteristics, and intended use. Center for Drug Evaluation and Research FDA NDA vs. ANDA Review Process Brand Name Drug NDA Requirements Generic Drug ANDA Requirements 1. Chemistry 1. Chemistry 2. Manufacturing 2. Manufacturing 3. Controls 3. Controls 4. Labeling 4. Labeling 5. Testing 5. Testing 6. Animal Studies 7. Clinical Studies 6. Bioequivalence 8. Bioavailability Center for Drug Evaluation and Research Wayne Weart, Pharm D Cost Effective Rx
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6 th Annual Primary Care Spring Conference Thursday, April 12, 2012<br />
Exclusivity Incentives<br />
FDA<br />
• NCE protection - 5 years<br />
• New salt or ester - 3 years<br />
• New use or dosage form - 3 years<br />
• Orphan drug status – 7 years<br />
Center for Drug Evaluation and Research<br />
Generic Incentives<br />
FDA<br />
• All approved products eligible for generic<br />
competition<br />
• Eliminated requirement for duplicative clinical<br />
trials<br />
• Created a regulatory process for faster<br />
approval of generic drugs<br />
Center for Drug Evaluation and Research<br />
Wayne Weart, Pharm D<br />
Cost Effective Rx
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