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.
Laura Helbling
On January 31, a whole lot of people were wondering what the Food & Drug Administration would tell Orexigen about...
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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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A new pilot aims to take Brazil closer to ‘digital transformation.’
Two pharmacies, a medical spa and a telehealth company voluntarily removed efficacy, safety and quality claims for compounded GLP-1 products after innovator companies filed challenges with the National Advertising Division.
The Council of the EU has made several key amendments to the legislative reform package, which it will now negotiate with the European Parliament.
The UK regulator wants to help companies to develop bacteriophages for the treatment of infections. Its first guidance on this topic offers advice to researchers and sets out the regulatory requirements they will need to meet.
