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Quality Systems

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August 2nd 2001
Changes and Challenges for CDER

The Center for Drug Evaluation and Research is adopting new approaches to how it oversees the development and approval of new drugs and how it ensures the safe use of prescription drugs by the public.

July 1st 2001

The Role of USP in the Assessment of Microbiological Quality of Pharmaceuticals

July 1st 2001

The Future State of Computer Validation, Part I

July 1st 2001

What Is the "Correct" Method to Use for Particle-Size Determination?

February 1st 1999

Reportable Values for Out-of-Specification Test Results