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PDUFA 2008 – New Submisison Fees for 505(b)(2) Applications

FDA announced that for 2008 the full application fee for a 505(b)(2) that requires a clinical study will be $1,178,000.  In addition, the establishment fee is $392,700 and the product fee is $65,030.  Small  businesses (defined as entities, including affiliates, with less than 500 employees) may request a  waiver of the PDUFA review fee for first submission; subsequent submissions are paid at the current rates.  All companies must pay the establishment and product fees.

For more information about user fees, see the FDA site.