FDA’s Message To Patient Advocates: Efforts On Engagement Are Only The Beginning

06 Apr 2016

• By Kate Rawson

Food & Drug Administration officials used a day-long public meeting to reassure patient advocates that the agency’s efforts to enhance patient engagement in the drug development process have only just begun, and that many more steps will need to be taken before FDA can deem patient-focused drug development a complete success.

FDA’s embrace of patient-focused drug development means recognizing that “moving the freight” in drug reviews cannot be the sole focus of rank-and-file reviewers.

FDA’s role as a “production shop” tasked with the constant job of “moving the freight” in the form of regulatory...

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

19 Sep 2024

• By Neena Brizmohun

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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16 Sep 2024

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