Regulatory library

21 CFR Part 314

Part 314 covers applications to market a new drug. Its rules on reporting changes decide when a change to equipment or a process must be reported to FDA before or after it is made.

ValDoc's library holds 1 provision of 21 CFR Part 314. This page is guidance in our words. The regulation's own text governs.

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Thirty minutes. Bring one piece of equipment.

Provisions in ValDoc's library

  1. 21 CFR 314.70; 314.97

    Unchanged since

    Supplements and other changes to an approved NDA; Supplements and other changes to an approved ANDA

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See your own equipment in ValDoc.

Bring one piece of equipment, or one you plan to buy, and we’ll walk it through ValDoc with you, from its intended use to the signed record.

Thirty minutes. Bring one piece of equipment.