Read Books Online and Download eBooks, EPub, PDF, Mobi, Kindle, Text Full Free.
Drug User Fees
Download Drug User Fees full books in PDF, epub, and Kindle. Read online Drug User Fees ebook anywhere anytime directly on your device. Fast Download speed and no annoying ads. We cannot guarantee that every ebooks is available!
Author :United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions Publisher : ISBN 13 : Total Pages :96 pages Book Rating :4.0/5 ( download)
Book Synopsis Drug User Fees by : United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions
Download or read book Drug User Fees written by United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions and published by . This book was released on 2008 with total page 96 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.
Author :United States Government Accountability Office Publisher :Createspace Independent Publishing Platform ISBN 13 :9781977513137 Total Pages :56 pages Book Rating :4.5/5 (131 download)
Book Synopsis Generic Drug User Fees by : United States Government Accountability Office
Download or read book Generic Drug User Fees written by United States Government Accountability Office and published by Createspace Independent Publishing Platform. This book was released on 2017-09-22 with total page 56 pages. Available in PDF, EPUB and Kindle. Book excerpt: Nearly 90 percent of prescription drugs dispensed in the United States are generic drugs. According to FDA, an increasing volume of generic drug applications over the past decades stressed its ability to review applications efficiently. GDUFA granted FDA the authority to collect user fees from the generic drug industry to supplement resources for the generic drug program. In return, FDA committed to meeting certain performance goals related to the timely review of generic drug applications and to implementing review process improvements. GAO was asked to examine FDA's implementation of GDUFA. In this report, GAO (1) examines how user fees supported the generic drug program, (2) describes FDA's improvements to the generic drug application review process, and (3) analyzes changes in generic drug application review times. GAO reviewed laws and regulations; FDA policy, guidance, the GDUFA Commitment Letter, and GDUFA financial reports from fiscal years 2013 through 2016; FDA data on application review times from fiscal years 2012 through 2015; and interviewed officials from FDA, generic drug manufacturers, and trade associations.
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:
Author :United States. Congress. House. Committee on Commerce. Subcommittee on Health and the Environment Publisher : ISBN 13 : Total Pages :200 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 200 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 :132 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 132 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. Senate. Committee on Labor and Human Resources Publisher : ISBN 13 : Total Pages :72 pages Book Rating :4.0/5 (1 download)
Book Synopsis User Fees for the Food and Drug Administration by : United States. Congress. Senate. Committee on Labor and Human Resources
Download or read book User Fees for the Food and Drug Administration written by United States. Congress. Senate. Committee on Labor and Human Resources and published by . This book was released on 1992 with total page 72 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Food and Drug Administration : effect of user fees on drug approval times, withdrawals, and other agency activities : report to the chairman, Committee on Health, Education, Labor, and Pensions, U.S. Senate by :
Download or read book Food and Drug Administration : effect of user fees on drug approval times, withdrawals, and other agency activities : report to the chairman, Committee on Health, Education, Labor, and Pensions, U.S. Senate written by and published by DIANE Publishing. This book was released on with total page 36 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis The Generic Drug User Fee Amendments by : Ernst R. Berndt
Download or read book The Generic Drug User Fee Amendments written by Ernst R. Berndt and published by . This book was released on 2017 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Regulation can influence the structure, conduct and performance of consumer product markets and the structure of product markets can influence regulation. Since the vast majority of prescription drugs consumed by Americans are generic, the structure of the U.S. generic prescription drug market is of wide interest. The supply of prescription drugs in the U.S. is also heavily regulated by the U.S. Food and Drug Administration (FDA). We describe events leading up to the passage and implementation of the Generic Drug User Fee Amendments in 2012 (GDUFA I), and compare its FDA commitments, provisions, goals and fee structure to that of the 1992 Prescription Drug User Fee Act (PDUFA) for branded drugs. Although GDUFA I expires September 30, 2017, reauthorization for GDUFA II is currently underway and is likely to shift the user fee structure away from annual facility fees to annual program fees. We explain how the fee structure of GDUFA I, and that being considered for GDUFA II, erects barriers to entry and creates scale and scope economies for incumbent manufacturers of generic drugs. Furthermore, in order to implement fees under GDUFA I, FDA required the submission of self-reported data on generic manufacturing practices including domestic and foreign active pharmaceutical ingredient (API) and finished dosage form (FDF) facilities. These data provide an unprecedented window into the recent evolution of generic drug manufacturing markets. Our analyses of these data suggest that generic drug manufacturing in 2017 is quite concentrated: a very large portion of ANDA holders have small portfolios consisting of less than five ANDAs, while a small number of very large ANDA holders have portfolios consisting of hundreds or even thousands of ANDAs. The number of API and FDF facilities have each declined by approximately 10-11% between 2013 and 2017. Furthermore, in 2017, generic manufacturing is largely foreign and has become increasingly so since 2013. We discuss the implications of the current structure of the U.S. generic prescription drug market for GDUFA II ratification and implementation.
Book Synopsis FDA User Fees by : United States. General Accounting Office
Download or read book FDA User Fees written by United States. General Accounting Office and published by . This book was released on 1994 with total page 56 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis F. D. A. User Fees by : DIANE Publishing Company
Download or read book F. D. A. User Fees written by DIANE Publishing Company and published by DIANE Publishing. This book was released on 1995-08 with total page 56 pages. Available in PDF, EPUB and Kindle. Book excerpt: Focuses on weather the data mandated by the Prescription Drug User Fee Act will be sufficient to evaluate how well the Act has achieved its goal of getting drugs to patients sooner. Charts & tables
Author :United States. Congress Publisher :Createspace Independent Publishing Platform ISBN 13 :9781983923081 Total Pages :128 pages Book Rating :4.9/5 (23 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 2018-01-17 with total page 128 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 Tenth Congress, first session, April 17, 2007.
Author :United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health Publisher : ISBN 13 : Total Pages :224 pages Book Rating :4.:/5 (319 download)
Book Synopsis FDA User Fees 2012 by : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health
Download or read book FDA User Fees 2012 written by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and published by . This book was released on 2013 with total page 224 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :United States. Congress Publisher :Createspace Independent Publishing Platform ISBN 13 :9781984104960 Total Pages :90 pages Book Rating :4.1/5 (49 download)
Book Synopsis Drug User Fees by : United States. Congress
Download or read book Drug User Fees written by United States. Congress and published by Createspace Independent Publishing Platform. This book was released on 2018-01-22 with total page 90 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug user fees : enhancing patient access and drug safety : hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Tenth Congress, first session, on examining enhancing patient access and drug safety relating to prescription drug user fees, including S. 484, March 14, 2007.
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.
Author :United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions Publisher : ISBN 13 : Total Pages :24 pages Book Rating :4.:/5 (327 download)
Book Synopsis Animal Drug User Fee Act of 2003 by : United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions
Download or read book Animal Drug User Fee Act of 2003 written by United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions and published by . This book was released on 2003 with total page 24 pages. Available in PDF, EPUB and Kindle. Book excerpt: