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Concept
Conditional Approval
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Summary
Conditional Approval
is a
Regulatory decision
that allows a product, such as a drug or medical device, to be marketed based on
Preliminary evidence
of
Efficacy And Safety
, while additional data is collected post-approval. This mechanism accelerates access to
Potentially beneficial products
in
Urgent situations
, balancing the need for
Rapid availability
with
Ongoing Evaluation
of
Long-term Outcomes
.
Concepts
Regulatory Affairs
Clinical Trials
Post-market Surveillance
Risk-benefit Analysis
Accelerated Approval
Evidence-based Medicine
Pharmacovigilance
Health Policy
Pre-approval Process
Relevant Degrees
Law and Jurisprudence 50%
Business and Management 30%
Medical Sciences 20%
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