GAO user fee study
General Accounting Office continuing investigation of user fees at FDA. In a brief presentation at the NAPM annual meeting on Jan. 24 in Puerto Rico, GAO representative William Bedwell noted that GAO, under the direction of the Senate appropriations subcmte., is conducting an audit to determine whether user fees at FDA are appropriate. According to Bedwell, GAO is considering a $100,000 fee per full NDA submission; a $10,000 fee per ANDA; $500 for a supplemental NDA; and an as yet undetermined amount for an IND. Bedwell was at NAPM to solicit comments from generic mfrs. on the potential impact of such a fee system
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