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Biotech / Medical : Biotech Valuation

CRSP 53.51

-1.3%

Jan 16 9:30 AM EST

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To: Biomaven who wrote (14702)	12/16/2004 3:34:52 PM
From: tom pope	Read Replies (1) of 52153

Google to the rescue: What is a 505(b)(2) Application? The 505(b)(2) FDA approval mechanism is an attractive alternative that companies should consider when preparing regulatory strategies and submissions for innovative dosage forms or delivery routes for pre-viously approved drugs. Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act was established by the Hatch-Waxman Amendments of 1984 to allow sponsors to obtain approval of new drug applications (NDAs) based upon “full reports of investigations” establishing a drug’s safety and efficacy where such investigations “were not conducted by or for the [505(b)(2)] applicant and for which the applicant has not obtained a right of reference or use from the person by or for whom the investigations were conducted” — 21 U.S.C. § 355(b)(2). Thus, a 505(b)(2) application permits a sponsor to rely upon the FDA’s findings of safety and efficacy for a previously approved drug product without requiring the sponsor to obtain a right of reference from the original applicant. The 505(b)(2) sponsor must pro-vide any additional clinical data necessary to demonstrate the safety and effectiveness of differences between the original drug and the 505(b)(2) drug, so while unnecessary dupli-cation of preclinical and certain human studies is avoided, specific studies may be required to establish the relevance and applicability of prior findings for your particular product formulation — 21 C.F.R. § 314.54. In addition to permitting reliance upon the FDA’s prior findings of safety and effective-ness for previously approved drugs, section 505(b)(2) continues to allow reliance on third party data that is available in published literature and which establishes the safety and effectiveness of a drug. The ability to rely upon published studies existed even prior to the 1984 Hatch-Waxman Amendments and is the source of the historic Paper NDA reference.

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