Drug Approval

/ˈdrʌɡ əˈpruːvəl/

Definitions

  1. (n.) The legal authorization process by which governmental regulatory agencies formally approve a pharmaceutical drug for market use after evaluating its safety, efficacy, and quality.
    The company's new medication received drug approval from the FDA after extensive clinical trials.

Forms

  • drug approval
  • drug approvals

Commentary

Drug approval is primarily a formal regulatory process distinct from general contract or transaction approval; precise terminology is critical in drafting to avoid ambiguity between regulatory consent and commercial contracts.

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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