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Office of Specialty Medicine - Division of Imaging and …

    https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-specialty-medicine-division-imaging-and-radiation-medicine-dirm
    The Division of Imaging and Radiation Medicine (DIRM) is responsible for drug products used in the image-based diagnosis and monitoring of diseases. …

CDER Offices and Divisions | FDA

    https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/cder-offices-and-divisions
    Division of Imaging and Radiation Medicine (DIRM) Division of Ophthalmology (DO) Office of Therapeutic Biologics and Biosimilars (OTBB) Clinical Outcome Assessments (COA) …

Center for Devices and Radiological Health | FDA

    https://www.fda.gov/about-fda/fda-organization/center-devices-and-radiological-health
    We assure that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. We provide …

CDRH Management Directory by Organization | FDA

    https://www.fda.gov/about-fda/cdrh-offices/cdrh-management-directory-organization
    CDRH Management Directory by Organization | FDA CDRH Management Directory by Organization Print This information is current as of December 21, 2022 …

Guidance Documents (Medical Devices and Radiation …

    https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products
    Center for Devices and Radiological Health Standard Operating Procedure (SOP) - Level 1, Immediately in Effect Guidance Documents on Premarket Data Issues (PDF - 484KB) …

Division of Hematologic Malignancies 1 (DHM1) | FDA

    https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/division-hematologic-malignancies-1-dhm1
    Division of Hematologic Malignancies 1 (DHM1) 5901-B Ammendale Road Beltsville, MD 20705-1266 Phone: (301) 796-4969 Fax: (301) 837-6142 Resources For …

Office of Cardiology, Hematology, Endocrinology and …

    https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-cardiology-hematology-endocrinology-and-nephrology-division-non-malignant-hematology-dnh
    Office of Cardiology, Hematology, Endocrinology and Nephrology - Division of Non-Malignant Hematology (DNH) The Division of Non-Malignant Hematology …

CFR - Code of Federal Regulations Title 21 - Food and …

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=864
    Subpart I - Hematology Reagents § 864.8100 - Bothrops atrox reagent. § 864.8150 - Calibrator for cell indices. § 864.8165 - Calibrator for hemoglobin or hematocrit …

022494Orig1s000 - accessdata.fda.gov

    https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022494Orig1s000OtherR.pdf
    Division of Medical Imaging and Hematology Application Number: NDA 22-494 Name of Drug: Sodium Fluoride (F-18) Injection Applicant: National Cancer Institute (NCI) Date: …

DEPARTMENT OF HEALTH & HUMAN SERVICES …

    https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019339s038ltr.pdf
    Please refer to your supplemental new drug application dated February 3, 2009, received February 4, 2009, submitted under section 505(b) of the Federal Food, Drug, and …



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