Accelerated Drug Approval: Access to Foreign Therapies
New rules may speed up access to drugs approved in certain countries, such as the United Kingdom. This means citizens could get faster access to new therapies already available abroad. It also introduces new rules for assessing the safety and effectiveness of these drugs.
Key points
Drugs approved in certain countries (e.g., UK) may be approved faster for sale in the US.
Confirmation of safety, effectiveness, and manufacturer's ability to produce the drug safely is required.
A special advisory committee of experts will be established to evaluate foreign drugs.
Drug approval decisions will be publicly available, along with their rationale.
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