A Republican accelerated approval reform proposal attempts to expand eligibility for the US Food and Drug Administration’s expedited pathway and eschews automatic expiration dates for product clearances.
GOP Accelerated Approval Proposal Could Expand Eligibility For US FDA Pathway
The rival to House Energy and Commerce Committee Chair Frank Pallone’s bill would not set expiration dates for accelerated approvals.
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Not all companies will be able to access joint scientific consultations under the EU Health Technology Assessment Regulation, but success is still possible for those that engage with national agencies early on, says EUCOPE’s Alexander Natz.
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Industry lobbing for pharmaceuticals to be exempt from President Trump’s sweeping US tariffs appears to have paid off.