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Prescription Drug User Fee Act Pdufa
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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 Publisher : ISBN 13 : Total Pages :140 pages Book Rating :4.0/5 (9 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 140 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:
Author :United States. Congress. House. Committee on Commerce. Subcommittee on Health and the Environment Publisher : ISBN 13 : Total Pages :140 pages Book Rating :4.F/5 ( 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 140 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Prescription Drug User Fee Act (PDUFA) by :
Download or read book Prescription Drug User Fee Act (PDUFA) written by and published by . This book was released on 2013 with total page 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 :320 pages Book Rating :4.0/5 ( download)
Book Synopsis Discussion Drafts Concerning Prescription Drug User Fee Act Reauthorization, Medical Device User Fee and Modernization Act Reauthorization, Drug Safety, and Certain Pediatric Pharmaceutical and Device Legislation by : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health
Download or read book Discussion Drafts Concerning Prescription Drug User Fee Act Reauthorization, Medical Device User Fee and Modernization Act Reauthorization, Drug Safety, and Certain Pediatric Pharmaceutical and Device Legislation 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 320 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Evaluation of the Adjustment for Changes in Review Activities Applied to the Prescription Drug User Fee ACT (Pdufa) IV Workload Adjuster for Fy 2009 by : Food and Food and Drug Administration
Download or read book Evaluation of the Adjustment for Changes in Review Activities Applied to the Prescription Drug User Fee ACT (Pdufa) IV Workload Adjuster for Fy 2009 written by Food and Food and Drug Administration and published by CreateSpace. This book was released on 2014-10-31 with total page 36 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Prescription Drug User Fee Act (PDUFA) authorizes the Food and Drug Administration (FDA) to collect user fees for reviewing and processing applications for the approval of certain human drug and biological products. There are generally four types of applications reviewed: New Drug Applications/Biologics License Applications (NDAs/BLAs); Investigational New Drug Applications (INDs); Efficacy Supplements; and Manufacturing Supplements.1 More information on the Prescription Drug User Fee Act can be found at the following website: http: //www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/default.htm
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 (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 Assessing the Impacts of the Prescription Drug User Fee Acts (PDUFA) on the FDA Approval Process by : Ernst R. Berndt
Download or read book Assessing the Impacts of the Prescription Drug User Fee Acts (PDUFA) on the FDA Approval Process written by Ernst R. Berndt and published by . This book was released on 2004 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Congress enacted and renewed the Prescription Drug User Fee Acts (PDUFA) in 1992, and renewed it in 1997 and 2002, mandating FDA performance goals in reviewing and acting on drug applications within specified time periods. In turn, the FDA was permitted to levy user fees on drug sponsors submitting applications to the FDA. While PDUFA mandated action or review times, its ultimate impacts on actual final drug approval times are unknown. We model and quantify the impact of PDUFA-I and II on drug approval times, since these approval dates are the ones most directly related to new medicines becoming available to benefit patients.
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 The FDA Medical Device User Fee Program by : Judith A. Johnson
Download or read book The FDA Medical Device User Fee Program written by Judith A. Johnson and published by Createspace Independent Pub. This book was released on 2012-07-06 with total page 38 pages. Available in PDF, EPUB and Kindle. Book excerpt: On June 20, 2012, the House of Representatives passed, by voice vote and under suspension of the rules, S. 3187 (EAH), the Food and Drug Administration Safety and Innovation Act, as amended. This bill would reauthorize the FDA prescription drug and medical device user fee programs (which would otherwise expire on September 30, 2012), create new user fee programs for generic and biosimilar drug approvals, and make other revisions to other FDA drug and device approval processes. It reflects bicameral compromise on earlier versions of the bill (S. 3187 [ES], which passed the Senate on May 24, 2012, and H.R. 5651 [EH], which passed the House on May 30, 2012). The following CRS reports provide overview information on FDA's processes for approval and regulation of drugs: CRS Report R41983, How FDA Approves Drugs and Regulates Their Safety and Effectiveness, by Susan Thaul; CRS Report RL33986, FDA's Authority to Ensure That Drugs Prescribed to Children Are Safe and Effective, by Susan Thaul; CRS Report R42130, FDA Regulation of Medical Devices, by Judith A. Johnson; CRS Report R42508, The FDA Medical Device User Fee Program, by Judith A. Johnson. (Note: The rest of this report has not been updated since April 24, 2012.) The Food and Drug Administration (FDA) is the agency responsible for the regulation of medical devices. These are a wide range of products that are used to diagnose, treat, monitor, or prevent a disease or condition in a patient. A company must obtain FDA's prior approval or clearance before marketing many medical devices in the United States. The Center for Devices and Radiological Health (CDRH) within FDA is primarily responsible for medical device review and regulation. Congress first gave FDA the authority to collect user fees from medical device companies in the Medical Device User Fee and Modernization Act of 2002 (P.L. 107-250). The purpose of the user fee program is to help reduce the time in which FDA can review and make decisions on marketing applications. Lengthy review times affect the industry, which waits to market its products, and patients, who wait to use these products. The user fee law provides a revenue stream for FDA; in conjunction, the agency negotiates with industry to set performance goals for the premarket review of medical devices. Reauthorization of FDA's medical device user fees last occurred in 2007, just before the FDA's authority would expire, via the Medical Device User Fee Amendments of 2007 (MDUFA II). Current authority will expire on October 1, 2012. On February 1, 2012, FDA announced that it had reached “an agreement in principle” with the medical device industry on proposed recommendations for the second reauthorization—referred to as MDUFA III. A draft MDUFA III package, composed of statutory language and the FDA industry agreement on performance goals and procedures, was posted on the FDA website on March 14, 2012, and a public meeting describing the draft was held on March 28, 2012. The 30-day comment period on the draft ended April 16, 2012. Following review of the comments, FDA may revise the recommendation and then is to submit the final package to Congress. Since medical device user fees were first collected in FY2003, they have comprised an increasing proportion of FDA's device budget. Medical device user fees have raised a number of concerns, prompting Congress to carefully consider issues such as which agency activities could use fees, how user fees can be kept from supplanting federal funding, and which companies should qualify as a small business and pay a reduced fee. Congress is also considering reauthorization of the Prescription Drug User Fee Act (PDUFA) as well as new proposals for a Generic Drug User Fee Act and a Biosimilars User Fee Act. It is likely that these three will be combined with MDUFA III along with a variety of related and unrelated issues.
Book Synopsis The Prescription Drug User Fee Act (DFUFA) by : Susan Thaul
Download or read book The Prescription Drug User Fee Act (DFUFA) written by Susan Thaul and published by . This book was released on 2007 with total page 15 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis The Prescription Drug User Fee Act by :
Download or read book The Prescription Drug User Fee Act written by and published by . This book was released on 2008 with total page 15 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Food And Drug Administration by : Janet Heinrich
Download or read book Food And Drug Administration written by Janet Heinrich and published by DIANE Publishing. This book was released on 2002-07-31 with total page 51 pages. Available in PDF, EPUB and Kindle. Book excerpt: In 1992, the Prescription Drug User Fee Act (PDUFA) was enacted to provide additional resources for the FDA to speed up the process of reviewing applications for new drugs & biological products. This report examines: (1) how PDUFA has affected the funding & approval times for FDA's review of new drug & biologic applications, (2) whether PDUFA has had an effect on the funding & oper. of FDA's non-PDUFA activities, (3) whether the workload, attrition, & non-professional development of FDA reviewers have changed since the user fee program was reauthorized in 1997, & (4) how the rate of drug withdrawals from the market has changed since PDUFA was enacted in 1992 & what actions are being taken by FDA to monitor adverse drug effects. Charts & tables.
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 Reauthorization of the Prescription Drug User Fee Act by : United States House of Representatives
Download or read book Reauthorization of the Prescription Drug User Fee Act written by United States House of Representatives and published by . This book was released on 2020-03-05 with total page 134 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.