Drug Regulatory Approval

/ˈdrʌɡ ˌrɛɡjʊlətəri əˈpruːvəl/

Definitions

  1. (n.) The official authorization granted by a regulatory agency permitting a pharmaceutical drug or medical product to be marketed or sold after evaluation of safety, efficacy, and quality.
    The company awaited drug regulatory approval before launching their new medication in the market.

Forms

  • drug regulatory approval

Commentary

This term specifically refers to the legal authorization stage in the lifecycle of a drug, involving compliance with regulatory standards; precise usage requires clarity on jurisdiction and agency involved.

This glossary is for general informational and educational purposes only. Definitions are jurisdiction-agnostic but reflect terminology and concepts primarily drawn from English and American legal traditions. Nothing herein constitutes legal advice or creates a lawyer-client relationship. Users should consult qualified counsel for advice on specific matters or jurisdictions.

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