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    What is office of generic drugs OGD? USFDA, generic drugs, CDER
    Author: Freyr Solutions
    Website: https://www.freyrsolutions.com/blog/effective-regulatory-strategies-for-medical-devices-registration
    Added: Thu, 17 Jun 2021 13:43:09 +0000
    Category: Health
    Printable version | Email | Bookmark

    The Food and Drugs Administration’s Office of Generic Drugs (OGD) is a division under the Center for Drug Evaluation in Research (CDER) that focuses on the approval and facilitation of generic drugs. The purpose of the OGD is to ensure that the drug products distributed in the United States (US) are of high quality, and are safe and effective to use. The OGD ensures that the generic drugs distributed in the US have the same active ingredient, strength, dosage form, and route of administration as the brand-name drug.

    Responsibilities of the OGD
    To approve generic drugs by reviewing abbreviated new drug applications (ANDAs)
    To act as the central point of communication between the FDA and the applicants
    To guide and oversee the Regulatory scenarios of generic drugs
    To ensure that the Generic Drug User Fee Amendments commitments are fulfilled
    To conduct research as per the GDUFA Regulatory Science Plan
    Investigate adverse event reports or similar reports related to generic drugs by interacting with various healthcare providers
    Offices Under the OGD
    Office of Generic Drugs Immediate Office
    Office of Bioequivalence
    Office of Generic Drug Policy
    Office of Regulatory Operations
    Office of Research and Standards
    The review process of the OGD
    Facilitating approval of drugs by managing the Regulatory process
    Initiating generic drugs research
    Gathering and publishing the data & reports on the development & review of generic drugs
    Providing educational material and related information on generic drugs
    The OGD was set up by the FDA to ensure the safety and efficacy of the generic drugs distributed in the US. Are you aligned with the regulations of OGD? Reach out to Freyr for compliance. sales@freyrsolutions.com.

    View all Freyr Solutions's articles


    About the Author:
    This article talks about the effective regulatory strategies for Medical Devices registration across the globe.

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