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FDA Seeks Comment On Fit-For-Purpose COAs Guidance

On June 29, the FDA released the new guidance, Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical. ....

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FDA Seeks Comment On ICH Q9(R1) Quality Risk Management

FDA Seeks Comment On ICH Q9(R1) Quality Risk Management
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FDA Seeks Comment On ICH Q9(R1) Quality Risk Management

ICH has revised Q9 Quality Risk Management, and it provides principles and tools for quality risk management that can be applied throughout the. ....

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FDA Updates Guidance For Investigating OOS Test Results for Pharma Production

FDA's CDER has released a guidance sharing the agency's recommendations on how to evaluate out-of-specification (OOS) test results, including. ....

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FDA Publishes Guidance For Biopharma Container Labels Carton Labeling Design

The scope of this new FDA guidance includes prescription drug products marketed under an approved NDA or ANDA, prescription drugs marketed without an. ....

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