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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.
Mark durivage
Radiological health
Patient specific health
Drug administration
Quality systems compliance
Drug development
Drug evaluation
Biologics evaluation
Patient focused drug development
Modifying fit for purpose clinical outcome
Outcome assessments
Conceptual framework
Interest assessed
Two concepts
Interest with indirect relationships
Specific health experiences
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