Faster Drug Access: Approving Therapies from Other Countries
New rules could speed up access to drugs already approved in selected countries, potentially bringing new therapies to market faster. Citizens may gain access to needed medications, especially for unmet medical needs, provided strict safety criteria are met.
Key points
Allows faster approval for drugs already legally marketed in other countries.
The drug must be safe, effective, and meet high manufacturing standards.
Expedited approval applies to drugs with an urgent public health need in the U.S.
The decision-making process for approval is limited to 180 days.
Expired
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