$17
FDA 21 CFR PART 58
2016
GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES
- Format:
- Language(s) :
- Published :
- English
- 04/01/2016
(a) This part prescribes good laboratory practices for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products regulated by the Food and Drug Administration, including food and color additives, animal food additives, human and animal drugs, medical devices for human use, biological products, and electronic products. Compliance with this part is intended to assure the quality and integrity of the safety data filed pursuant to sections 406, 408, 409, 502, 503, 505, 506, 510, 512–516, 518–520, 721, and 801 of the Federal Food, Drug, and Cosmetic Act and sections 351 and 354–360F of the Public Health Service Act.
(b) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted.
| FDA 21 CFR PART 58 | |
|---|---|
| STANDARD INFO: | |
| Standard Name | FDA 21 CFR PART 58 |
| Scope | GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES |
| Publisher | FDA - Food and Drug Administration |
| Languages | English |
| State | [ Revised ] |
| Publication Year | 2016 |
| Most recent Version | MOST RECENT |
| Whether to be replaced | |
| Addendum | |
| FILE INFO: | |
| Edition | 16 |
| File Size | 1 file , 220 KB |
| Number of Pages | 14 |
| Published | 04/01/2016 |
| FDA 21 CFR PART 58 | ||
|---|---|---|
| History | Publisher Year | |
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