Crawford Investigation Finds "No Evidence" On Three Of Four Personal Conduct Allegations

The HHS Inspector General finds no evidence of impropriety by the FDA commissioner nominee on three of four allegations relating to his interactions with an agency subordinate but cites "inconsistencies" concerning a fourth allegation. A Senate Health Committee majority staffer says a vote on Crawford's nomination is likely by August.

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Ocaliva: Still No Clarity On Why EU Court Opposed Revocation Of Approval

 

Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.

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Brazil Pilots Digital Drug Pack Inserts

 

A new pilot aims to take Brazil closer to ‘digital transformation.’

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Postmarketing Surprise Is Latest Plot Twist For Novavax’s COVID-19 Vaccine BLA

 

Three weeks after its user fee goal date, the FDA demanded a postmarketing commitment “to generate additional data,” Novavax said.

Stand-Alone PDP Market Lives to Fight Another Day, Enrollment Data Shows

 
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No mass exodus was seen from stand-alone prescription drug plans to Medicare Advantage drug plans between 2024 and 2025, according to one actuary.

Gene Therapy Sponsor INTERACT, Pre-IND Meeting Confusion Lingers Despite FDA Guidance

 
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PhRMA questioned whether proof-of-concept studies are needed before an INTERACT meeting and said a draft guidance describing the timing of definitive toxicology studies creates confusion.