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FDA DRAFT Guidance for Industry Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices

FDA DRAFT Guidance for Industry Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices

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Published by David Harlow
This draft guidance is intended to describe FDA’s current thinking about how manufacturers, packers, and distributors (firms) of prescription human and animal drugs (drugs) and medical devices for human use (devices) should respond, if they choose to respond, to misinformation related to a firm’s own FDA-approved or -cleared products when that information is created or disseminated by independent third parties on the Internet or through social media or other technological venues (Internet/social media), regardless of whether that misinformation appears on a firm’s own forum or an independent third-party forum or website. This draft guidance responds to (among other things) stakeholder requests for specific guidance regarding a firm’s voluntary correction of misinformation when that misinformation is created or disseminated by an independent third party.
This draft guidance is intended to describe FDA’s current thinking about how manufacturers, packers, and distributors (firms) of prescription human and animal drugs (drugs) and medical devices for human use (devices) should respond, if they choose to respond, to misinformation related to a firm’s own FDA-approved or -cleared products when that information is created or disseminated by independent third parties on the Internet or through social media or other technological venues (Internet/social media), regardless of whether that misinformation appears on a firm’s own forum or an independent third-party forum or website. This draft guidance responds to (among other things) stakeholder requests for specific guidance regarding a firm’s voluntary correction of misinformation when that misinformation is created or disseminated by an independent third party.

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Published by: David Harlow on Jun 17, 2014
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08/18/2014

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Guidance for Industry
Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices
 DRAFT GUIDANCE
This guidance document is being distributed for comment purposes only.
Comments and suggestions regarding this draft document should be submitted within 90 days of  publication in the
Federal Register 
 of the notice announcing the availability of the draft guidance. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the
 Federal Register 
. For questions regarding this draft document, contact (CDER) Julie Chronis at 301-796-1200; (CBER) Office of Communication, Outreach and Development at 800-835-4709 or 240-402-7800; (CVM) Thomas Moskal at 240-276-9300; or (CDRH) Deborah Wolf at 301-796-5732.
 
U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) Center for Veterinary Medicine (CVM) Center for Devices and Radiological Health (CDRH) June 2014 Advertising
 
 
Guidance for Industry
Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices
 Additional copies are available from:
Office of Communications, Division of Drug  Information Center for Drug Evaluation and Research Food and Drug Administration 10903 New Hampshire Ave., Bldg. 51, rm. 2201 Silver Spring, MD 20993-0002 Tel: 301-796-3400; Fax: 301-847-8714;  E-mail: druginfo@fda.hhs.gov  http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm Communications Staff (CVM) Center for Veterinary Medicine Food and Drug Administration 7519 Standish Place, HFV-12  Rockville, MD 20855 Tel: 240-276-9300;  E-mail:  AskCVM@fda.hhs.gov  http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm Office of Communication, Outreach and Development Center for Biologics Evaluation and Research Food and Drug Administration 10903 New Hampshire Ave., WO71, Room 3128 Silver Spring, MD 20993 Tel: 800-835-4709 or 240-402-7800;  E-mail: ocod@fda.hhs.gov http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm
Office of the Center Director Guidance and Policy Development Center for Devices and Radiological Health Food and Drug Administration 10903 New Hampshire Ave., Bldg. 66, rm. 5431 Silver Spring, MD 20993-0002 Tel: 301-796-5900;  E-mail: CDRH-Guidance@fda.hhs.gov  http://www.fda.gov/MedicalDevices/DeviceRegulationand Guidance/GuidanceDocuments/default.htm 
U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) Center for Veterinary Medicine (CVM) Center for Devices and Radiological Health (CDRH) June 2014 Advertising

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