Department of Justice charges former associate general counsel with obstruction and making false statements to FDA; indictment alleges she signed letters to FDA denying off-label promotion and withheld physician slides.
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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.’
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.
The remarks from the new CBER director suggest Prasad will not be involved in most product-specific decisions.
