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2011-12-30
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Draft Guidance for Industry on Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices; Availability
Notices
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United States
Department of Health and Human Services
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United States Government Agency or Subagency
United States
Food and Drug Administration
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United States Government Agency or Subagency
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices.'' This draft guidance responds to stakeholder requests for specific guidance on FDA's current views on how manufacturers and distributors (firms) of prescription human and animal drug products and medical devices can respond to unsolicited requests for information about unapproved or uncleared indications or conditions of use (off- label information) related to their FDA-approved or cleared products. This draft guidance updates and clarifies FDA's policies on unsolicited requests for off-label information, including those that firms may encounter through emerging electronic media.
76 FR 82303
https://www.govinfo.gov/app/details/FR-2011-12-30/2011-33550
2011-33550
fr30de11-68
4160-01-P
Docket No. FDA-2011-D-0868
https://www.govinfo.gov/app/details/FR-2011-12-30/2011-33550
https://www.govinfo.gov/content/pkg/FR-2011-12-30/html/2011-33550.htm
https://www.govinfo.gov/content/pkg/FR-2011-12-30/pdf/2011-33550.pdf
4 p.
82303
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76 FR 82303
Draft Guidance for Industry on Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices; Availability; Federal Register Vol. 76, Issue
NOTICE
2011-33550
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2011-D-0868
4160-01-P
2011-33550
Notice.
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices.'' This draft guidance responds to stakeholder requests for specific guidance on FDA's current views on how manufacturers and distributors (firms) of prescription human and animal drug products and medical devices can respond to unsolicited requests for information about unapproved or uncleared indications or conditions of use (off- label information) related to their FDA-approved or cleared products. This draft guidance updates and clarifies FDA's policies on unsolicited requests for off-label information, including those that firms may encounter through emerging electronic media.
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comments on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by March 29, 2012. Submit written comments on the proposed collection of information by February 28, 2012.
Regarding human prescription drugs: Jean-Ah Kang, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Silver Spring, MD 20993, (301) 796-1200.
Draft Guidance for Industry; Availability:
Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices
,
http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm
http://www.regulations.gov
Federal Register
Vol. 76, no. 251
Office of the Federal Register, National Archives and Records Administration
2011-12-30
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Table of Contents:
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https://www.govinfo.gov/app/details/FR-2011-12-30
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https://www.govinfo.gov/app/details/FR-2011-12-30
https://www.govinfo.gov/content/pkg/FR-2011-12-30/pdf/FR-2011-12-30.pdf
https://www.govinfo.gov/content/pkg/FR-2011-12-30/xml/FR-2011-12-30.xml
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