Author: United States. Congress. Senate. Committee on Health, Education, Labor, and PensionsPublisher:
ISBN:
Category : Drug approval
Languages : en
Pages : 0
Book Description
FDA User Fee Agreements: Advancing Medical Product Regulation and Innovation for the Benefit of Patients, FDA Center Directors
Author: United States. Congress. Senate. Committee on Health, Education, Labor, and PensionsPublisher:
ISBN:
Category : Drug approval
Languages : en
Pages : 0
Book Description
FDA User Fee Agreements: Advancing Medical Product Regulation and Innovation for the Benefit of Patients
Author: United States. Congress. Senate. Committee on Health, Education, Labor, and PensionsPublisher:
ISBN:
Category : Drug approval
Languages : en
Pages : 0
Book Description
FDA User Fee Agreements
Author: United States. Congress. Senate. Committee on Health, Education, Labor, and PensionsPublisher:
ISBN:
Category : Drug approval
Languages : en
Pages : 88
Book Description
The FDA Medical Device User Fee Program
Author: Judith A. JohnsonPublisher: Createspace Independent Pub
ISBN: 9781478201458
Category : Medical
Languages : en
Pages : 38
Book Description
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.
FDA User Fees 2012
Author: United States. Congress. House. Committee on Energy and Commerce. Subcommittee on HealthPublisher:
ISBN:
Category : Drug approval
Languages : en
Pages : 224
Book Description
FDA User Fees
Author: United States. Congress. Senate. Committee on Health, Education, Labor, and PensionsPublisher:
ISBN:
Category : Drug approval
Languages : en
Pages : 96
Book Description
FDA User Fee Agreements
Author: United States. Congress. Senate. Committee on Health, Education, Labor, and PensionsPublisher:
ISBN:
Category : Drug approval
Languages : en
Pages :
Book Description
FDA User Fee Agreements: Improving Medical Product Regulation and Innovation For Patients, Part II, Senate Hearing 115-333, April 4, 2017, 114-1
Author: Publisher:
ISBN:
Category :
Languages : en
Pages :
Book Description
FDA User Fee Agreements: Improving Medical Product Regulation and Innovation for Patients, Part 1, S.HRG. 115-255, March 21, 2017, 115-1
Author: Publisher:
ISBN:
Category :
Languages : en
Pages :
Book Description
FDA Regulatory Affairs
Author: David MantusPublisher: CRC Press
ISBN: 1040079180
Category : Medical
Languages : en
Pages : 402
Book Description
FDA Regulatory Affairs is a roadmap to prescription drug, biologics, and medical device development in the United States. Written in plain English, the concise and jargon-free text demystifies the inner workings of the US Food and Drug Administration (FDA) and facilitates an understanding of how the agency operates with respect to compliance and product approval, including clinical trial exemptions, fast track status, advisory committee procedures, and more. The Third Edition of this highly successful publication: Examines the harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations on human drug, biologics and device development, research, manufacturing, and marketing Includes contributions from experts at organizations such as the FDA, National Institutes of Health (NIH), and PAREXEL Focuses on the new drug application (NDA) process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements Provides updates to the FDA Safety and Innovation Act (FDASIA), incorporating pediatric guidelines and follow-on biologics regulations from the 2012 Prescription Drug User Fee Act (PDUFA) V Explains current FDA inspection processes, enforcement options, and how to handle FDA meetings and required submissions Co-edited by an industry leader (Mantus) and a respected academic (Pisano), FDA Regulatory Affairs, Third Edition delivers a compilation of the selected US laws and regulations as well as a straightforward commentary on the FDA product approval process that’s broadly useful to both business and academia.
