food and drug administration amendments act of 2007

• Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Implementation of Sections 222, 223, and 224 of the Food and Drug Administration Amendments Act of 2007

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

• Federal Register Nbr. 77 FR 2068, January 13, 2012
• Notices
• Health and Human Services Department

• Draft Guidance for Industry on Direct-to-Consumer Television Advertisements-the Food and Drug Administration Amendments Act of 2007 Direct-to-Consumer Television Ad Pre-Dissemination Review Program; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Direct-to- Consumer Television Advertisements--FDAAA DTC Television Ad Pre- Dissemination Review Program.'' This draft guidance is intended to assist sponsors of human prescription drug products, including biological drug products, who are subject to the pre-dissemination review of television advertisements (TV ads) provision of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). (The term ``pre- dissemination review'' is used throughout the guidance to refer to review under the FD&C Act, which is entitled ``Prereview of Television Advertisements.'') The draft guidance describes which TV ads FDA intends to make subject to this provision, explains how FDA will no...

• Federal Register Nbr. 77 FR 14811, March 13, 2012
• Notices
• Health and Human Services Department

• Draft Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007

• FR, May 25, 2010
• Notices
• Food and Drug Administration

• Enantiomer Exclusivity Revisited - The Food and Drug Administration Amendments Act of 2007

Tucked away at the end of the Food and Drug Administration Amendments Act of 2007 (FDAAA) is a provision that modifies FDA's long-standing refusal to ...

• Mondaq Business Briefing
• United States Law Articles in English

• Reportable Food Registry as Required by the Food and Drug Administration Amendments Act of 2007

• FR, May 27, 2008
• Notices
• Food and Drug Administration

• New Report Addresses Potential Benefits and Shortcomings in Development of Risk Evaluation and Mitigation Strategies (Rems)

WASHINGTON, April 1 /PRNewswire-USNewswire/ -- Two years after the Food and Drug Administration Amendments Act of 2007 (FDAAA) gave FDA new powers to require Risk Evaluation and Mitigation Strategies (REMS) for higher risk drugs and biologics, a new report concludes that an optimal future for REMS is possible if the agency adopts a systems approach when designing REMS programs and takes advantage of new technologies -- from electronic medical records to genetic testing -- that are changing the way medicine is practiced. The result of a September 2009 workshop sponsored by the Society for Women's Health Research and facilitated by the Institute for Alternative Futures, the report -- Optimal Futures for Risk Evaluation and Mitigation Strategies -- concludes that FDA has the greatest poten...

• U.S. Newswire
• April 01, 2010

• Amendments to Regulations on Citizen Petitions, Petitions for Stay of Action, and Submission of Documents to Dockets

The Food and Drug Administration (FDA) is proposing to amend certain regulations relating to citizen petitions, petitions for stay of action, and the submission of documents to the Agency. In particular, the proposed rule would establish new regulations to implement certain provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which concern certain citizen petitions and petitions for stay of action (PSAs) that involve a request for FDA to take any form of action relating to a pending abbreviated new drug application (ANDA) or 505(b)(2) application. We are making these changes to implement provisions of the Food and Drug Administration Amendments Act of 2007 (FDAAA).

• Federal Register Nbr. 77 FR 25, January 03, 2012
• Proposed rules
• Health and Human Services Department

• Enantiomer Exclusivity Revisited - The Food and Drug Administration Amendments Act of 2007.

Tucked away at the end of the Food and Drug Administration Amendments Act of 2007 (FDAAA) is a provision that modifies FDA's long-standing refusal to ...

• Mondaq Business Briefing
• Nbr. 2007, January 2007

• Guidance for Industry, Third Parties and Food and Drug Administration Staff; Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot Program; Availability

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot Program.'' This guidance document is intended to provide information on the implementation of the Food and Drug Administration Amendments Act of 2007 (FDAAA), which amends the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This guidance document describes how FDA's Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) are implementing this provision of the law. The Pilot Program will be effective June 5, 2012.

• Federal Register Nbr. 77 FR 16036, March 19, 2012
• Notices
• Health and Human Services Department

• Issues and critiques of the forthcoming risk evaluation and mitigation strategy (REMS) for opioids in pain management.

... examine the history and suitability of the Food and Drug Administration's (FDA) Risk Evaluation an...(5) In 2007, of the 27,500 fatal unintended drug overdoses in ... channels for recommending legislative amendments, when needed, for achieving agency goals. As the a...

• Issues in Law & Medicine
• Vol. 27 Nbr. 2, September 2011