FDA's Compliance Policy Guide for Pedigree Requirements under 21 CFR Part 203
by FDA Center for Drug Evaluation and Research
This document is intended to clarify for FDA personnel and the regulated industry how the agency intends to prioritize its enforcement efforts regarding the pedigree requirements in 21 U.S.C. 353(e)(1)(A) and 21 CFR Part 203 during the first year after the effective date of 21 CFR Sections 203.3(u) and 203.50.
| Published: | 2006 |
| Format: | |
| Length: | 4 pages |
| Type: | White paper |
| Language: | English |
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