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  1. AUTHORIZATION definition: 1. official permission for something to happen, or the act of giving someone official permission to…. Learn more.

  2. Dec 18, 2020 · In most contexts, it’s perfectly acceptable to use “approval” and “authorization” interchangeably. But not at the Food and Drug Administration (FDA), and definitely not when it comes to ...

  3. AUTHORIZATION meaning: 1. official permission for something to happen, or the act of giving someone official permission to…. Learn more.

  4. The meaning of AUTHORIZATION is the act of authorizing.

    • Authorization
    • Approval
    • Clearance

    An Emergency Use Authorizationallows for the short-term use of a medical product. The FDA expects that the sponsor will be building a formal Biologic License Application (BLA) for when the public emergency has passed.

    “Approval” refers to the approval of a full application package: 1. Pre-Market Approval (PMA)for medical devises. 2. New Drug Application (NDA) approval for small molecules. 3. Biologics License Application (BLA)approval for biologics, including vaccines.

    Clearance is a more abbreviated process than an approval 1. Clinical trials for small molecules and biologics are considered “cleared” if the FDA does not provide negative feedback within 30 days of the Investigational New Drug (IND)application. 2. A medical device that is not novel and similar to an already approved device undergoes a process know...

  5. Mar 7, 2022 · Put simply, an emergency use authorization (EUA) is a tool the Food and Drug Administration (FDA) can use to expedite the availability of medical products, including drugs and vaccines, during a public health emergency. An EUA can only be granted when no adequate, approved, available alternatives exist, and when the known and potential benefits ...

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  7. authorization: 1 n official permission or approval Synonyms: authorisation , authority , sanction Type of: permission approval to do something n a document giving an official instruction or command Synonyms: authorisation , mandate Type of: instrument , legal document , legal instrument , official document (law) a document that states some ...

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