Laura Helbling
On January 31, a whole lot of people were wondering what the Food & Drug Administration would tell Orexigen about its application for the weight loss drug, Contrave. That day...
Just a Minute: The Final Step in Advisory Committee Process
FDA’s advisory committee process is a critical part of the new drug approval process. But the official record keeping of the committees is not: there is no real role for the “minutes” FDA publishes summarizing the panel deliberations.
More from Archive
• By
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.
• By
This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
• By
We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.
• By
A new pilot aims to take Brazil closer to ‘digital transformation.’