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Concept
Accelerated Approval
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Summary
Accelerated Approval
is a pathway used by the FDA to expedite the approval of drugs that address
Unmet Medical Needs
for
Serious Conditions
, based on
Surrogate Endpoints
that are reasonably likely to
Predict clinical benefit
. This process allows
Patients earlier access
to
Promising therapies
while requiring further
Post-marketing Studies
to confirm the
Anticipated benefits
.
Concepts
FDA
Surrogate Endpoint
Unmet Medical Need
Post-Marketing Study
Clinical Benefit
Expedited Drug Approval
Therapeutic Innovation
Regulatory Science
Conditional Approval
Relevant Degrees
Public and Professional Organization of Health 50%
General and Professional Pharmacy 30%
Animal Health and Veterinary Hygiene 20%
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