food and drug administration act

• Food and Drug Administration Modernization Act of 1997:

• FR, March 14, 2011
• Notices
• Food and Drug Administration

• 21 CFR 21.20 - Procedures for notice of Food and Drug Administration Privacy Act Record Systems.

• Code of Federal Regulations - Title 21: Food and Drugs

• Rep. Frank Pallone Jr. Holds a Hearing On the Food and Drug Administration's Globalization Act

HOUSE COMMITTEE ON ENERGY AND COMMERCE, SUBCOMMITTEE ON HEALTH HOLDS A HEARING ON THE FDA'S GLOBALIZATION ACT MAY 1, 2008 SPEAKERS: ...

• Political Transcript Wire
• August 26, 2009

• Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 028

The Food and Drug Administration (FDA) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA recognized consensus standards). This publication, entitled ``Modifications to the List of Recognized Standards, Recognition List Number: 028'' (Recognition List Number: 028), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.

• Federal Register Nbr. 77 FR 15765, March 16, 2012
• Notices
• Health and Human Services Department

• Food and Drug Administration Modernization Act of 1997:

• FR, August 02, 2011
• Notices
• Food and Drug Administration

• 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

• Food and Drug Administration Modernization Act of 1997:

• FR, October 04, 2010
• Notices
• Food and Drug Administration

• Draft Guidance for Industry on Direct-to-Consumer Television Advertisements-the Food and Drug Administration Amendments Act of 2007 Direct-to-Consumer Television Ad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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Direct-to- Consumer Television Advertisements--FDAAA DTC Television Ad Pre- Dissemination Review Program.''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: Food and Drug Administration Records Access Authority Under the Federal Food, Drug, and Cosmetic Act; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug, & Cosmetic Act.'' This draft guidance provides updated information pertaining to FDA's authority to access and copy records relating to food. It is a revision of FDA's November 2005 guidance entitled ``Guidance for Industry and FDA Staff: Guidance for Records Access Authority Provided in Title III, Subtitle A, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Final Guidance.''

• Federal Register Nbr. 77 FR 10753, February 23, 2012
• Notices
• Health and Human Services Department

• Agency Emergency Processing Under the Office of Management and Budget Review; Submission for Office of Management and Budget Review; Comment Request; Food and Drug Administration Food Safety Modernization Act: Economic Hardship Fee Reduction Guidance

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 (PRA). The proposed collection of information concerns a guidance document that outlines the criteria and the process through which firms may request a reduction of fees based on severe economic hardship of the FDA Food Safety Modernization Act (FSMA) reinspection and recall user fees that are mandated by the Federal Food, Drug, and Cosmetic Act (the FD&C Act).

• Federal Register Nbr. 76 FR 72712, November 25, 2011
• Notices
• Health and Human Services Department