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Author : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health
Publisher : Unknown
Page : 134 pages
File Size : 45,5 Mb
Release : 2002
Category : Drugs
ISBN : STANFORD:36105050256614
Author : United States. Congress. House. Committee on Commerce. Subcommittee on Health and the Environment
Publisher : Unknown
Page : 200 pages
File Size : 53,7 Mb
Release : 1997
Category : Law
ISBN : STANFORD:36105023756146
Author : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health
Publisher : Unknown
Page : 128 pages
File Size : 49,8 Mb
Release : 2008
Category : Business & Economics
ISBN : PSU:000065512937
Author : Agata Dabrowska,Susan Thaul
Publisher : Unknown
Page : 18 pages
File Size : 50,8 Mb
Release : 2017
Category : Fees, Administrative
ISBN : OCLC:1097483945
Author : Judith A. Johnson
Publisher : Createspace Independent Pub
Page : 38 pages
File Size : 40,8 Mb
Release : 2012-07-06
Category : Medical
ISBN : 1478201452
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 : Food and Food and Drug Administration
Publisher : CreateSpace
Page : 36 pages
File Size : 43,9 Mb
Release : 2014-10-31
Category : Electronic
ISBN : 1502918358
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
Author : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health
Publisher : Unknown
Page : 140 pages
File Size : 53,7 Mb
Release : 2002
Category : Drugs
ISBN : LOC:00095383889
Author : United States. Congress. House. Committee on Commerce. Subcommittee on Health and the Environment
Publisher : Unknown
Page : 140 pages
File Size : 46,5 Mb
Release : 1997
Category : Law
ISBN : PSU:000031672849
Author : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health
Publisher : Unknown
Page : 320 pages
File Size : 53,8 Mb
Release : 2008
Category : Medical
ISBN : PSU:000065512906
Author : United States. Congress. House. Committee on Commerce
Publisher : Unknown
Page : 144 pages
File Size : 43,8 Mb
Release : 1997
Category : Drugs
ISBN : PURD:32754067063945
Author : James C. Perry
Publisher : Nova Science Publishers
Page : 0 pages
File Size : 51,9 Mb
Release : 2014-02
Category : User charges
ISBN : 1629487740
The Food and Drug Administration Safety and Innovation Act (FDASIA), amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to expand the authority of the Food and Drug Administration (FDA) in performing its human drug, biological product, and medical device responsibilities. Frequently referred to as the user fee reauthorisation act, FDASIA does include four titles relating to user fees. This book focuses on these acts, as well as the prescription drug user fee act, the FDA medical device user fee program and discusses the proposed FDA user fee acts generic drug user fee amendments.
Author : Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Assessment of the US Drug Safety System
Publisher : National Academies Press
Page : 346 pages
File Size : 52,8 Mb
Release : 2007-02-27
Category : Medical
ISBN : 9780309133944
In the wake of publicity and congressional attention to drug safety issues, the Food and Drug Administration (FDA) requested the Institute of Medicine assess the drug safety system. The committee reported that a lack of clear regulatory authority, chronic underfunding, organizational problems, and a scarcity of post-approval data about drugs' risks and benefits have hampered the FDA's ability to evaluate and address the safety of prescription drugs after they have reached the market. Noting that resources and therefore efforts to monitor medications' riskâ€"benefit profiles taper off after approval, The Future of Drug Safety offers a broad set of recommendations to ensure that consideration of safety extends from before product approval through the entire time the product is marketed and used.
Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Committee on Pain Management and Regulatory Strategies to Address Prescription Opioid Abuse
Publisher : National Academies Press
Page : 483 pages
File Size : 51,7 Mb
Release : 2017-09-28
Category : Medical
ISBN : 9780309459570
Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain and containing the rising toll of the harms that can arise from the use of opioid medications. Chronic pain and opioid use disorder both represent complex human conditions affecting millions of Americans and causing untold disability and loss of function. In the context of the growing opioid problem, the U.S. Food and Drug Administration (FDA) launched an Opioids Action Plan in early 2016. As part of this plan, the FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to update the state of the science on pain research, care, and education and to identify actions the FDA and others can take to respond to the opioid epidemic, with a particular focus on informing FDA's development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring.
Author : Rita Ricardo Campbell
Publisher : Hoover Press
Page : 76 pages
File Size : 51,8 Mb
Release : 1976
Category : Medical
ISBN : 0817935533
Author : United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions
Publisher : Unknown
Page : 96 pages
File Size : 42,8 Mb
Release : 2008
Category : Medical
ISBN : PSU:000065503119
