FDA Confirmation Process Derailed: Time For Plan B?
• By Michael McCaughan and Ramsey Baghdadi
Senate Committee says it is investigating a conduct allegation raised about Crawford. Disclosure has the hallmarks of an attempt to torpedo the nomination – and helps shift debate over Crawford away from FDA's handling of Barr emergency contraceptive.
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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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Marcus Vass and Vladimir Murovec of international law firm Osborne Clarke tell the Pink Sheet what the government's planned HDRS might mean for industry, and how it compares with the European Health Data Space.
The European Health Data Space framework will allow companies to accelerate R&D processes and identify new molecular targets faster by facilitating centralized access to certain types of high-quality data, Finland’s Orion Pharma says.