The FDA has shelved its National Priority Voucher pilot, leaving sponsors that built CMC and launch-readiness plans around 1- to 2-month reviews facing uncertain timelines.
News|Articles|February 1, 2003
- Pharmaceutical Technology-02-01-2003
- Volume 2003 Supplement
- Issue 1
Understanding and Implementing Efficient Analytical Methods Development and Validation
Author(s)Jay Breaux, PhD
Analytical methods development and validation play important roles in the discovery, development, and manufacture of pharmaceuticals. The official test methods that result from these processes are used by quality control laboratories to ensure the identity, purity, potency, and performance of drug products.
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Articles in this issue
almost 24 years ago
Implementing Successful Stability Testing Operationsalmost 24 years ago
Choosing a Contract Research Organization for Analytical Testingalmost 24 years ago
Challenges, Considerations, and Benefits of Raw Materials TestingAdvertisement
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