Food and Drug Administration Regulations

/ˈfuːd ænd drʌg ədmɪnɪˈstreɪʃən ˌrɛɡjʊˈleɪʃənz/

Definitions

  1. (n.) Rules and standards issued by the Food and Drug Administration (FDA) to regulate the safety, efficacy, labeling, and marketing of food, drugs, medical devices, and related products in the United States.
    The manufacturer must comply with Food and Drug Administration Regulations before marketing the new drug.

Forms

  • food and drug administration regulations
  • food and drug administration regulation

Commentary

FDA regulations are a key subset of federal administrative law, governing product approval and compliance; practitioners should distinguish these regulations from statutory provisions and guidance documents.

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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