CFR section
21 CFR 58.195(b): Retention of records
PART 58-GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES · Subpart J-Records and Reports
Key facts
| Citation | 21 CFR 58.195(b) |
|---|---|
| Section | Retention of records |
| Part | PART 58-GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES |
| Subpart | Subpart J-Records and Reports |
| Subchapter | 21 CFR A General |
| Product types cited | General |
| Regulation text (excerpt) | (b) Except as provided in paragraph (c) of this section, documentation records, raw data and specimens pertaining to a nonclinical laboratory study and required to be made by this part shall be retained in the archive(s) for whichever of the following periods is shortest: (1) A period of at least 2 years following the date on which an application for a research or marketing permit, in support of which the results of the nonclinical laboratory study were submitted, is approved by the Food and… |
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