FDA 21 CFR 312: Investigational New Drug Application

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21 CFR 312 contains procedures and requirements governing the use of investigational new drugs.ﾠIt includes the procedures and requirements for FDA submission and review by of investigational new drug applications.

Sections most commonly cited in software related deficiencies include:ﾠﾠ

• 21 CFR 312.62(b) Investigator Record-keeping for Case Historiesﾠ
• 21 CFR 312.62(c) Investigator Record Retention