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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
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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:
Author :United States. Congress Publisher :Createspace Independent Publishing Platform ISBN 13 :9781983923746 Total Pages :318 pages Book Rating :4.9/5 (237 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
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 and published by Createspace Independent Publishing Platform. This book was released on 2018-01-17 with total page 318 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Tenth Congress, first session, Jun
Author :United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health Publisher : ISBN 13 : Total Pages : pages Book Rating :4.:/5 (122 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 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Report on the Activity of the Committee on Energy and Commerce for the ... Congress by : United States. Congress. House. Committee on Energy and Commerce
Download or read book Report on the Activity of the Committee on Energy and Commerce for the ... Congress written by United States. Congress. House. Committee on Energy and Commerce and published by . This book was released on 2009 with total page 312 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :United States. Congress. House. Committee on Energy and Commerce Publisher : ISBN 13 : Total Pages :312 pages Book Rating :4.3/5 (121 download)
Book Synopsis Report on the Activity of the Committee on Energy and Commerce for the One Hundred Tenth Congress by : United States. Congress. House. Committee on Energy and Commerce
Download or read book Report on the Activity of the Committee on Energy and Commerce for the One Hundred Tenth Congress written by United States. Congress. House. Committee on Energy and Commerce and published by . This book was released on 2009 with total page 312 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Report on the Activity of the Committee on Energy and Commerce for the 110th Congress, January 3, 2009, 110-2 House Report 110-937 by :
Download or read book Report on the Activity of the Committee on Energy and Commerce for the 110th Congress, January 3, 2009, 110-2 House Report 110-937 written by and published by . This book was released on 2009 with total page 310 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis House Hearing, 110th Congress by : U. S. Government Printing Office (Gpo)
Download or read book House Hearing, 110th Congress written by U. S. Government Printing Office (Gpo) and published by BiblioGov. This book was released on 2013-09 with total page 320 pages. Available in PDF, EPUB and Kindle. Book excerpt: The United States Government Printing Office (GPO) was created in June 1860, and is an agency of the U.S. federal government based in Washington D.C. The office prints documents produced by and for the federal government, including Congress, the Supreme Court, the Executive Office of the President and other executive departments, and independent agencies. A hearing is a meeting of the Senate, House, joint or certain Government committee that is open to the public so that they can listen in on the opinions of the legislation. Hearings can also be held to explore certain topics or a current issue. It typically takes between two months up to two years to be published. This is one of those hearings.
Author :United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health Publisher : ISBN 13 : Total Pages :134 pages Book Rating :4.F/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 134 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 :4.0/5 ( 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 Medical Device User Fee and Modernization Act (MDUFMA) Reauthorization by :
Download or read book Medical Device User Fee and Modernization Act (MDUFMA) Reauthorization written by and published by . This book was released on 2007 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Unless Congress acts to reauthorize it, the Food and Drug Administration's (FDA's) authority to collect user fees under the Medical Device User Fee and Modernization Act (MDUFMA; P.L. 107-250) and, by reference, FDA's obligation to meet related performance goals, will expire on October 1, 2007. According to the President's budget request, in FY2008, funds from a reauthorized MDUFMA would account for an estimated $47.5 million and 200 full-time equivalent employees (FTEs). This would comprise 16.6% of FDA's medical device review budget authority and 13.0% of its medical device review-related FTEs. While these numbers and percentages are not as high as those projected for collection under a similar FDA user fee authority related to prescription drugs (pursuant to the Prescription Drug User Fee Act), they are significant. For MDUFMA as passed in 2002 ("MDUFMA I"), the fee amounts and performance goals articulated and incorporated in statute were the result of an agreement between FDA and the medical device industry. In order to facilitate the reauthorization of MDUFMA ("MDUFMA II") in April 2007, the FDA and industry published the results of their negotiations with a notice of an April 30, 2007, public meeting on the topic. According to FDA, during the five years covered by the proposals (through 2012), FDA would receive approximately $287 million from user fees. This represents an increase from the $110 million FDA received during the first four years of the program. The industry agreement also calls for changes in the fee structure, performance goals, small business relief, and third party inspection program. In addition, the agreement reflects FDA's initiatives related to the regulation of in vitro diagnostic devices (laboratory tests). (MDUFMA I enabled third party inspections and set standards for the use of reprocessed single-use devices.) The details of the proposed MDUFMA II provisions have been incorporated into Senator Kennedy's bill, the Food and Drug Administration Revitalization Act as reported out of the Senate Health, Education, Labor, and Pensions Committee (S. 1082). The details of MDUFMA I and these proposals for MDUFMA II are discussed in this report, following an introduction to FDA's medical device review process. This report will be updated as needed.
Book Synopsis FDA's Authority to Ensure That Drugs Prescribed to Children Are Safe and Effective by : Susan Thaul
Download or read book FDA's Authority to Ensure That Drugs Prescribed to Children Are Safe and Effective written by Susan Thaul and published by Createspace Independent Pub. This book was released on 2012-07-06 with total page 28 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 November 10, 2011.) With the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA), Congress authorized the Food and Drug Administration (FDA) to offer drug manufacturers financial and regulatory incentives to test their products for use in children. Congress extended both programs with the FDA Amendments of 2007 (FDAAA) and, because of the programs' sunset date, must act before October 1, 2012, to continue them. This report presents the historical development of BPCA and PREA, their rationale and effect, and FDAAA's impact. The report also discusses pediatric drug issues that remain of concern to some in Congress. Most prescription drugs have never been the subject of studies specifically designed to test their effects on children. In these circumstances, clinicians, therefore, may prescribe drugs for children that FDA has approved only for adult use; this practice is known as off-label prescribing. Although some clinicians may believe that the safety and effectiveness demonstrated with adults would hold for younger patients, studies show that the bioavailability of drugs—that is, how much gets into a patient's system and is available for use—varies in children for reasons that include a child's maturation and organ development and other factors. The result of such off-label prescribing may be that some children receive ineffective drugs or too much or too little of potentially useful drugs; or that there may be side effects unique to children, including effects on growth and development. Drug manufacturers are reluctant to test drugs in children because of economic, ethical, legal, and other obstacles. Market forces alone have not provided manufacturers with sufficient incentives to overcome these obstacles. BPCA and PREA represent attempts by Congress to address the need for pediatric testing. FDA had tried unsuccessfully to spur pediatric drug research through administrative action before 1997. With the FDA Modernization Act of 1997 (FDAMA, P.L. 105-115), Congress provided an incentive: if a manufacturer completed pediatric studies that FDA requested, the agency would extend the company's market exclusivity for that product for six months, not approving the sale of another manufacturer's product during that period. In 2002, BPCA (P.L. 107-109) reauthorized this program for five years. In 1998, to obtain pediatric use information on the drugs that manufacturers were not studying, FDA published the Pediatric Rule, which required manufacturers to submit pediatric testing data at the time of all new drug applications.
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:
Download or read book CIS Annual written by and published by . This book was released on 2007 with total page 448 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Medical Device User Fees and User Fee Acts by : Erin D. Williams
Download or read book Medical Device User Fees and User Fee Acts written by Erin D. Williams and published by . This book was released on 2010 with total page 29 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :United States. Congress Publisher :Createspace Independent Publishing Platform ISBN 13 :9781983923029 Total Pages :156 pages Book Rating :4.9/5 (23 download)
Book Synopsis Reauthorization of the Medical Device User Fee and Modernization Act by : United States. Congress
Download or read book Reauthorization of the Medical Device User Fee and Modernization Act written by United States. Congress and published by Createspace Independent Publishing Platform. This book was released on 2018-01-17 with total page 156 pages. Available in PDF, EPUB and Kindle. Book excerpt: Reauthorization of the Medical Device User Fee and Modernization Act : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Tenth Congress, first session, May 16, 2007.
Book Synopsis Congressional Record by : United States. Congress
Download or read book Congressional Record written by United States. Congress and published by . This book was released on 2007 with total page 924 pages. Available in PDF, EPUB and Kindle. Book excerpt: