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User Fees For The Food And Drug Administration
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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 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. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and the Environment Publisher : ISBN 13 : Total Pages :204 pages Book Rating :4.3/5 (91 download)
Book Synopsis Medical Device User Fees by : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and the Environment
Download or read book Medical Device User Fees 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 1994 with total page 204 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis User Fee Programs for Medical Products at the Food and Drug Administration by :
Download or read book User Fee Programs for Medical Products at the Food and Drug Administration written by and published by . This book was released on with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: 18 GAO Analysis-Impact of User Fees: Budget Details, Federal Government, HHS, and FDA Funding, Fiscal Year 2008 19 GAO Analysis-Impact of User Fees: Budget Details • In 2009, GAO reported that total funding for medical product programs increased from about $562 million in fiscal year 1999 to about $1.2 billion in fiscal year 2008. [...] 22 GAO Analysis-Impact of User Fees: Budget Details, Portion of Total Medical Product Program Funding Allocated to User Fees Activities and Other Program Activities, Fiscal Years 1999 and 2008 23 GAO Analysis-Impact of User Fees: Staffing Details • Staffing resources for FDA's medical product programs increased between fiscal year 1999 and fiscal year 2008. [...] • The number of medical product program FTEs funded by user fees increased 113 percent-from 856 FTEs in fiscal year 1999 to 1,825 FTEs in fiscal year 2008-while FTEs funded by fiscal year appropriations declined 7 percent, or from 4,069 FTEs in fiscal year 1999 to 3,802 FTEs in fiscal year 2008. [...] 31 GAO Analysis-Impact of User Fees on Non-User Fee Activities: Examination of Advertising and Promotional Materials • Funding for FDA's oversight of drug advertising and promotion increased 167 percent from about $4 million in fiscal year 2004 to about $10 million in fiscal year 2008. [...] 20548 202-512-3407 [email protected] User Fee Programs for Medical Products at the Food and Drug Administration Introduction Drug Application Review Times Before User Fees Prescription Drug User Fee Act (PDUFA) Drug Application Review Times Following the Enactment of User Fees Medical Device Review Times Before User Fees Medical Device Review Times Before User Fees Medical Device User Fee and Modern.
Book Synopsis Food and Drug Administration by : Randall B. Williamson
Download or read book Food and Drug Administration written by Randall B. Williamson and published by DIANE Publishing. This book was released on 2007-08 with total page 16 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Food & Drug Amin. (FDA) is responsible for approving medical devices -- such as catheters & artificial hearts -- to provide reasonable assurance of their safety & effectiveness. Congress enacted the Medical Device User Fee & Modernization Act of 2002 (MDUFMA) which authorizes FDA to charge user fees for some device applications & not others. In FY2005, FDA collected $31 million in user fees from device applications. This report provides revenue information for: (1) companies that qualified as small businesses under the MDUFMA user fee program in FY2006; & (2) companies publicly traded in the U.S. that submitted device applications subject to user fees & did not qualify as small businesses under MDUFMA in FY2006. Charts.
Author :United States. Congress. Senate. Committee on Labor and Human Resources Publisher : ISBN 13 : Total Pages :58 pages Book Rating :4.:/5 (19 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 58 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:
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. 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 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:
Book Synopsis Impact of User Fees on Changes Within the Food and Drug Administration (FDA) by : Gary W. Lawson
Download or read book Impact of User Fees on Changes Within the Food and Drug Administration (FDA) written by Gary W. Lawson and published by . This book was released on 2005 with total page 422 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 Fees Not Charged for Processing Applications for New Drugs by : United States. General Accounting Office
Download or read book Fees Not Charged for Processing Applications for New Drugs written by United States. General Accounting Office and published by . This book was released on 1971 with total page 28 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 . This book was released on 2013-01-07 with total page 39 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Food and Drug Admin. (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 U.S. 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 (MDUFA; 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. Contents of this report: Introduction; Current Law; MDUFA Impact on FDA Review Time and Budget; MDUFA III Proposal. Figures and tables. This is a print on demand report.
Book Synopsis To Assess the Impact of Proposed FDA User Fees on Small Business by : United States. Congress. Senate. Committee on Small Business
Download or read book To Assess the Impact of Proposed FDA User Fees on Small Business written by United States. Congress. Senate. Committee on Small Business and published by . This book was released on 1989 with total page 140 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 :The Law The Law Library Publisher :Createspace Independent Publishing Platform ISBN 13 :9781727699005 Total Pages :24 pages Book Rating :4.6/5 (99 download)
Book Synopsis Tobacco Products, User Fees, Requirements for the Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and Importers of Tobacco (Us Food and Drug Administration Regulation) (Fda) (2018 Edition) by : The Law The Law Library
Download or read book Tobacco Products, User Fees, Requirements for the Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and Importers of Tobacco (Us Food and Drug Administration Regulation) (Fda) (2018 Edition) written by The Law The Law Library and published by Createspace Independent Publishing Platform. This book was released on 2018-10 with total page 24 pages. Available in PDF, EPUB and Kindle. Book excerpt: Tobacco Products, User Fees, Requirements for the Submission of Data Needed To Calculate User Fees for Domestic Manufacturers and Importers of Tobacco (US Food and Drug Administration Regulation) (FDA) (2018 Edition) The Law Library presents the complete text of the Tobacco Products, User Fees, Requirements for the Submission of Data Needed To Calculate User Fees for Domestic Manufacturers and Importers of Tobacco (US Food and Drug Administration Regulation) (FDA) (2018 Edition). Updated as of May 29, 2018 The Food and Drug Administration (FDA or we) is issuing a final rule that requires domestic tobacco product manufacturers and importers to submit information needed to calculate the amount of user fees assessed under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). The United States Department of Agriculture (USDA) has been collecting this information and providing FDA with the data FDA needs to calculate the amount of user fees assessed to tobacco product manufacturers and importers. USDA intends to cease collecting this information starting in fiscal year 2015 (October 2014). Consistent with the requirements of the FD&C Act, the final rule requires the submission of this information to FDA instead of USDA. This book contains: - The complete text of the Tobacco Products, User Fees, Requirements for the Submission of Data Needed To Calculate User Fees for Domestic Manufacturers and Importers of Tobacco (US Food and Drug Administration Regulation) (FDA) (2018 Edition) - A table of contents with the page number of each section