Pediatric Study Timelines Could Change Under Senate PDUFA Bill
Provisions aimed at earlier planning and completion of pediatric studies are part of user fee legislative package Senate committee will vote on May 10; measure also calls for FDA guidance on pediatric studies of molecularly targeted cancer drugs but does not require such trials.
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Maarten Meulenbelt of law firm Sidley Austin explains the pricing challenges that face pharmaceutical companies in Europe during the remainder of 2022 and how they may have to adjust their strategies in order to succeed.
Off-Label Discussion, But No Additions, For House User Fee Bill
Several Republicans remain interested in expanding off-label communications, suggesting the issue could come up outside the user fee context, potentially as part of future drug pricing discussions.
User Fee Bill Caught In Comey Firing Tidal Wave
Senate committee forced to postpone mark-up of FDA user fee reauthorization legislation; drug pricing fight may be postponed by hearing pledge.