CFR section
21 CFR 58.185(a): Reporting of nonclinical laboratory study results
PART 58-GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES · Subpart J-Records and Reports
Key facts
| Citation | 21 CFR 58.185(a) |
|---|---|
| Section | Reporting of nonclinical laboratory study results |
| Part | PART 58-GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES |
| Subpart | Subpart J-Records and Reports |
| Subchapter | 21 CFR A General |
| Product types cited | Drugs, General |
| Regulation text (excerpt) | (a) A final report shall be prepared for each nonclinical laboratory study and shall include, but not necessarily be limited to, the following: (1) Name and address of the facility performing the study and the dates on which the study was initiated and completed. (2) Objectives and procedures stated in the approved protocol, including any changes in the original protocol. (3) Statistical methods employed for analyzing the data. (4) The test and control articles identified by name, chemical… |
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