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Off-Label Use of Marketed Drug or Device

    https://www.fda.gov/regulatory-information/search-fda-guidance-documents/label-and-investigational-use-marketed-drugs-biologics-and-medical-devices
    For a BIOLOGICAL BLOOD or VACCINE product, contact: Office of Communication, Outreach and Development Center for Biologic Evaluation and Research Food and Drug Administration 10903 New Hampshire...

Responding to Unsolicited Requests for Off-Label …

    https://www.fda.gov/regulatory-information/search-fda-guidance-documents/responding-unsolicited-requests-label-information-about-prescription-drugs-and-medical-devices
    Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices GUIDANCE DOCUMENT Responding to Unsolicited Requests for Off …

Device Labeling | FDA - U.S. Food and Drug Administration

    https://www.fda.gov/medical-devices/overview-device-regulation/device-labeling
    Introduction to Medical Device Labeling Label vs. Labeling The U.S. Food and Drug Administration (FDA) develops and administers regulations under authority …

FDA Issues Final Rule Clarifying Evidence of Off-Label …

    https://www.dechert.com/knowledge/onpoint/2021/8/fda-issues--final-rule--on-drug-and-medical-device-marketing.html
    August 09, 2021. Key Takeaways. Following more than five years of revisions and delays, the U.S. Food and Drug Administration (“FDA”) published its final “intended use” rule (the …



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