User Fees for the Food and Drug Administration: Hearing of the Committee on Labor and Human Resources, United States Senate, One Hundred Second Session, on Examining Proposed Legislation to Authorize the Food and Drug Administration to Charge User Fees to Prescription Drug Manufacturers to Increase Resources to Improve the Review Time on Drug Applications, September 22, 1992, Volume 4 |
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12 months 50 percent agency annual application fee appropriations believe benefit biologics review biopharmaceuticals biotechnology products board committee budget CBER CDER Center for Biologics Center for Drugs Commissioner Kessler commitment concerned Congress cortisone DAVID KESSLER Dingell and Waxman diseases draft Drug Administration DRUG APPLICATIONS drug approval process Drug Evaluations drug review drugs and biologics Evaluations and Review FDA review FDA user fees Food and Drug FTEs going issue JANE PORTER Kennedy and Senator legislation look Mossinghoff orphan drug over-the-counter drug PARKINSON'S DISEASE performance goals pharmaceutical industry Pharmaceutical Manufacturers PLAS PMA Board prepared statement prescription drugs product application product fees product review proposal reasonable revenue review and approval review process SAFE AND EFFECTIVE Senator DURENBERGER Senator Hatch Senator Simon SKALETSKY small businesses small companies staff supplements Thank U.S. SENATE user fee bill user fee program user fee system