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Prescription Drug User Fee Act Of 1992
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Book Synopsis Prescription Drug User Fee Act of 1992 by :
Download or read book Prescription Drug User Fee Act of 1992 written by and published by . This book was released on 1992 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Prescription Drug User Fee Act of 1992 by :
Download or read book Prescription Drug User Fee Act of 1992 written by and published by . This book was released on 1997 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Prescription Drug User Fee Act of 1992 (PDUFA) enabled the Food and Drug Administration (FDA) to assess user fees on research-based pharmaceutical companies to be used solely to accelerate the process for reviewing and approving applications for new drugs. In at least two respects there have tangible accomplishments. First, since 1993, one-third less time was required to review and approve new research-based drugs than in the years prior to PDUFA implementation. Second, the number of new drugs approved by FDA rose by one-third. But PDUFA was not intended to and does not address other related issues of the total regulatory process for new drug development and approval, pricing of new drugs, or the approval of generic drugs.
Book Synopsis The Effect of the Prescription Drug User Fee Act of 1992 (PDUFA) on the Access and Safety of New Prescription Drugs in the United States by : Randy Steiner
Download or read book The Effect of the Prescription Drug User Fee Act of 1992 (PDUFA) on the Access and Safety of New Prescription Drugs in the United States written by Randy Steiner and published by . This book was released on 2005 with total page 494 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Prescription Drug User Fee Act of 1992. September 22, 1992. -- Committed to the Committee of the Whole House on the State of the Union and Ordered to be Printed by : United States. Congress. House. Committee on Energy and Commerce
Download or read book Prescription Drug User Fee Act of 1992. September 22, 1992. -- Committed to the Committee of the Whole House on the State of the Union and Ordered to be Printed written by United States. Congress. House. Committee on Energy and Commerce and published by . This book was released on 1992 with total page 35 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :United States. Congress. House. Committee on Commerce. Subcommittee on Health and the Environment Publisher : ISBN 13 : Total Pages :152 pages Book Rating :4.0/5 (18 download)
Book Synopsis Reauthorization of the Prescription Drug User Fee Act and FDA Reform by : United States. Congress. House. Committee on Commerce. Subcommittee on Health and the Environment
Download or read book Reauthorization of the Prescription Drug User Fee Act and FDA Reform written by United States. Congress. House. Committee on Commerce. Subcommittee on Health and the Environment and published by . This book was released on 1997 with total page 152 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health Publisher : ISBN 13 : Total Pages :128 pages Book Rating :4.0/5 ( download)
Book Synopsis Reauthorization of the Prescription Drug User Fee Act by : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health
Download or read book Reauthorization of the Prescription Drug User Fee Act written by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and published by . This book was released on 2008 with total page 128 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Prescription Drug User Fee Act of 1992 by : United States. Congress. House. Committee on Energy and Commerce
Download or read book Prescription Drug User Fee Act of 1992 written by United States. Congress. House. Committee on Energy and Commerce and published by . This book was released on 1992 with total page 35 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health Publisher : ISBN 13 : Total Pages :128 pages Book Rating :4.X/5 (5 download)
Book Synopsis Reauthorization of the Prescription Drug User Fee Act by : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health
Download or read book Reauthorization of the Prescription Drug User Fee Act written by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and published by . This book was released on 2002 with total page 128 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis The Prescription Drug User Fee Act (PDUFA) by :
Download or read book The Prescription Drug User Fee Act (PDUFA) written by and published by . This book was released on 2007 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Prescription Drug User Fee Act (PDUFA), first enacted in 1992 and reauthorized twice (referred to as PDUFA II and PDUFA III), gives the Food and Drug Administration (FDA) a revenue source -- fees paid by the pharmaceutical manufacturers -- to supplement, not replace, direct appropriations. The impetus behind the 1992 law was the length of time from a manufacturer's submission of a New Drug Application (NDA) or a Biologics License Application (BLA) to FDA and the agency's issuing its decision on approval or licensure, which FDA attributed to constrained review-staff time. This delay affected patients and the drug manufacturers. PDUFA I goals were to diminish the backlog of applications at FDA and to increasingly shorten the time from submission to decision. PDUFA II expanded the goals to include activities related to the investigational phases of a new drug's development; it also added the goal of increasing FDA communications with industry and consumer groups. PDUFA III authorized activities both at earlier (preclinical development) and at later (up to three years after drug approval) stages of drug research and development. FDA set these performance goals in conjunction with the drug manufacturers, and the Secretary of Health and Human Services (HHS) submitted them in letters to the chairs of the relevant congressional authorizing committees. The Secretary also submits annual PDUFA performance and financial reports. Based on its stated goals, PDUFA has generally been viewed as a success. FDA has added review staff and reduced its review times. It has also standardized the information required for applications and developed computer tools to use electronically submitted data. Criticism of PDUFA fits into three categories. First, the fees have not fully covered FDA's increased costs, despite the provisions that Congress implemented. Second, because PDUFA has directed a majority of the collected fees toward premarket review of applications, some people see PDUFA as responsible for what they view as the agency's increasing focus on premarket activities in contrast to the relatively slower increase in postmarket surveillance and safety studies and enforcement. They point to the fees' funding 20% of the salaries and expenses in FDA overall and 30% within the human drug program (with a yet higher proportion among the premarket drug review staff). Finally, some critics think that, through its provision of fees, the industry has too much influence over FDA actions. In January 2007, FDA released its proposal for PDUFA IV. The goals, developed through consultation with Congress, industry, and healthcare consumers and professionals, focus on securing FDA's sound financial footing, and enhancing both premarket review and the postmarket safety system.
Book Synopsis Cost and Consequence by : Evan J. Zucker
Download or read book Cost and Consequence written by Evan J. Zucker and published by . This book was released on 2004 with total page 160 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :United States. Congress Publisher :Createspace Independent Publishing Platform ISBN 13 :9781983615313 Total Pages :132 pages Book Rating :4.6/5 (153 download)
Book Synopsis Reauthorization of the Prescription Drug User Fee Act by : United States. Congress
Download or read book Reauthorization of the Prescription Drug User Fee Act written by United States. Congress and published by Createspace Independent Publishing Platform. This book was released on 2018-01-08 with total page 132 pages. Available in PDF, EPUB and Kindle. Book excerpt: Reauthorization of the Prescription Drug User Fee Act : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Seventh Congress, second session, March 6, 2002.
Book Synopsis Prescription Drug User Fee Reauthorization and Drug Regulatory Modernization Act of 1997 by : United States. Congress. House. Committee on Commerce
Download or read book Prescription Drug User Fee Reauthorization and Drug Regulatory Modernization Act of 1997 written by United States. Congress. House. Committee on Commerce and published by . This book was released on 1997 with total page 144 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Fda User Fees by : U S Government Accountability Office (G
Download or read book Fda User Fees written by U S Government Accountability Office (G and published by BiblioGov. This book was released on 2013-06 with total page 52 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pursuant to a congressional request, GAO reviewed the legislative requirement that the Food and Drug Administration (FDA) annually report certain data to Congress, focusing on whether the data are sufficient to evaluate how well the Prescription Drug User Fee Act of 1992 has achieved its goal of getting drugs to patients sooner. GAO found that: (1) the act's reporting requirements, if fully complied with, will provide sufficient information on the timeliness of FDA performance, but FDA performance is not the sole determinant of how long it takes for a new drug to become available to the public; (2) FDA performance is measured from the official filing of a new drug application to FDA approval; (3) FDA is held accountable for only those processes over which it has control; (4) additional data are needed to evaluate whether the act has improved the public health because there is no requirement to measure how long it takes for drugs to become available to patients, compare timeliness data before and after the institution of user fees, and determine other effects of the act besides timeliness improvements, if any; and (5) drug availability can be delayed by incomplete applications, labeling disputes, and the time the sponsor takes to reply to FDA queries and actions.
Book Synopsis The Prescription Drug User Fee Act (PDUFA) by : Susan Thaul
Download or read book The Prescription Drug User Fee Act (PDUFA) written by Susan Thaul and published by . This book was released on 2008 with total page 15 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and the Environment Publisher : ISBN 13 : Total Pages :64 pages Book Rating :4.F/5 ( download)
Book Synopsis User Fees for Prescription Drugs by : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and the Environment
Download or read book User Fees for Prescription Drugs written by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and the Environment and published by . This book was released on 1992 with total page 64 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Prescription Drug User Fee Act (PDUFA) by : Agata Dabrowska
Download or read book Prescription Drug User Fee Act (PDUFA) written by Agata Dabrowska and published by . This book was released on 2017 with total page 18 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis The Prescription Drug User Fee Act by : Donna U. Vogt
Download or read book The Prescription Drug User Fee Act written by Donna U. Vogt and published by . This book was released on 2002 with total page 23 pages. Available in PDF, EPUB and Kindle. Book excerpt: