CFR section
21 CFR 312.57(d): Recordkeeping and record retention
PART 312-INVESTIGATIONAL NEW DRUG APPLICATION · Subpart D-Responsibilities of Sponsors and Investigators
Key facts
| Citation | 21 CFR 312.57(d) |
|---|---|
| Section | Recordkeeping and record retention |
| Part | PART 312-INVESTIGATIONAL NEW DRUG APPLICATION |
| Subpart | Subpart D-Responsibilities of Sponsors and Investigators |
| Subchapter | 21 CFR D Drugs Human |
| Product types cited | Drugs, General |
| Regulation text (excerpt) | (d) A sponsor shall retain reserve samples of any test article and reference standard identified in, and used in any of the bioequivalence or bioavailability studies described in, § 320.38 or § 320.63 of this chapter, and release the reserve samples to FDA upon request, in accordance with, and for the period specified in § 320.38. |
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