Requesting methods validation for abbreviated new drug applications
by FDA Center for Drug Evaluation and Research
This white paper by the Food and Drug Administration's Center for Drug Evaluation and Research (CDER) describes situations in which review chemists should request validation of analytical procedures by FDA laboratories for abbreviated new drug applications (ANDAs), and establishes the Office of Generic Drugs' (OGD) approval policy when laboratory results are pending. This paper discusses establishment evaluation requests (EERs), methods validation and verification, policy, responsibilities and regulatory methods.
| Published: | 2006 |
| Format: | |
| Length: | 6 pages |
| Type: | White paper |
| Language: | English |
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