Drug Approval Process

Drug Approval Process - Drug Approval Process Fall'07 Dr....

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Drug Approval Process Fall’07 Dr. Dhing – PAS 3301
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Agenda Drug Patent Brand “Innovator Drug” – New Drug Generic Drug vs. Brand Drug IND/NDA/ANDA Preclinical Trials Clinical Trials (Phases 1-4) Orphan Drugs
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Kefauver Harris Amendments Act of 1962 required manufacturers to establish the safety and effectiveness of all drugs on the market and made the FDA responsible for regulating the drug industry.
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Introduction A “New Drug” requires a patent to be filed with the FDA Patent: a drug is usually under a patent that allows ONLY the company that developed the drug to sell it Patent ranges from 15-20 years
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Generic Drug Contains same API as original drug Considered bioequivalent to original drug Do not have to prove safety/efficacy No clinical trials/testing necessary Therefore, company only incurs manufacturing costs, and thus, high profit at low prices
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Generic Drug Availability dependent on patent: -expiration, validity, infringement, enforcement Patent = non-renewable Generic Drug companies must file ANDA
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ANDA Abbreviated NDA Clinical investigations omitted
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This note was uploaded on 04/07/2008 for the course PAS 3301 taught by Professor Dhing during the Fall '08 term at St. Johns Duplicate.

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Drug Approval Process - Drug Approval Process Fall'07 Dr....

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