United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2004_register executive 2010-09-23 article Notices D09002ee1c81688a0 D09002ee1c816894a United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA) is announcing the availability of three draft guidances for industry designed to improve information provided to consumers and health care practitioners by medical product firms about medical products and health conditions. The three guidances are entitled: "Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements" (Brief Summary Guidance), "Help-Seeking and Other Disease Awareness Communications by or on Behalf of Drug and Device Firms" (Disease Awareness Guidance), and "Consumer-Directed Broadcast Advertising of Restricted Devices " (Device Broadcast Advertising Guidance). FDA is also announcing the withdrawal of the draft guidance for industry entitled "Using FDA- Approved Patient Labeling in Consumer-Directed Print Advertisements." 69 FR 6308 https://www.govinfo.gov/app/details/FR-2004-02-10/04-2728 04-2728 fr10fe04-108 4160-01-S Docket No. 2004D-0042 https://www.govinfo.gov/app/details/FR-2004-02-10/04-2728 https://www.govinfo.gov/content/pkg/FR-2004-02-10/html/04-2728.htm https://www.govinfo.gov/content/pkg/FR-2004-02-10/pdf/04-2728.pdf 2 p. 6308 6309 69 FR 6308 Draft Guidances for Industry on Improving Information About Medical Products and Health Conditions; Withdrawal; Availability; Federal Register Vol. 69, Issue NOTICE 04-2728 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2004-05-10 Docket No. 2004D-0042 4160-01-S 04-2728 Notice.

The Food and Drug Administration (FDA) is announcing the availability of three draft guidances for industry designed to improve information provided to consumers and health care practitioners by medical product firms about medical products and health conditions. The three guidances are entitled: "Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements" (Brief Summary Guidance), "Help-Seeking and Other Disease Awareness Communications by or on Behalf of Drug and Device Firms" (Disease Awareness Guidance), and "Consumer-Directed Broadcast Advertising of Restricted Devices " (Device Broadcast Advertising Guidance). FDA is also announcing the withdrawal of the draft guidance for industry entitled "Using FDA- Approved Patient Labeling in Consumer-Directed Print Advertisements."

Written comments on the draft guidances may be submitted by May 10, 2004. General comments on agency guidance documents are welcome at any time. Regarding prescription human drugs: Lesley R. Frank, Center for Drug Evaluation and Research (HFD-42), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-2831. Regarding prescription human biological products: Glenn N. Byrd, Center for Biologics Evaluation and Research (HFM-600), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827- 3028. Regarding medical device products: Deborah Wolf, Center for Devices and Radiological Health (HFZ-300), 2098 Gaither Road, Rockville, MD 20850, 301-594-4589. Reports and guidance documents; availability, etc.: Medical products and health conditions; information improvement, http://www.fda.gov/cber/guidelines http://www.fda.gov/cder/ddmac/DTCmeeting2003.html http://www.fda.gov/cder/guidance/index.htm http://www.fda.gov/ohrms/dockets/default.htm Vol. 69, no. 27 Office of the Federal Register, National Archives and Records Administration 2004-02-10 continuing daily deposited born digital 397 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2004-02-10 P0b002ee1809722ca 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr10fe04 https://www.govinfo.gov/app/details/FR-2004-02-10 https://www.govinfo.gov/content/pkg/FR-2004-02-10/pdf/FR-2004-02-10.pdf https://www.govinfo.gov/content/pkg/FR-2004-02-10/xml/FR-2004-02-10.xml fdlp 6139 6524 DGPO 2010-09-23 2024-06-07 FR-2004-02-10 machine generated eng FR FR-2004-02-10 69 27