GBL product maker RenewTrient Research asks FDA for proof that gamma butyrolactone presents a risk to consumers in a Feb. 11 letter to the agency. The Cocoa Beach, Fla.-based firm requests an FDA response within 30 days and, depending on the strength of the evidence against GBL, says it may return the supplement ingredient to the market. FDA has not yet responded to the letter.
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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.
