CDER’s Drug Quality Office Separates Oversight Of ‘New’ And ‘Lifecycle’ Products
This article was originally published in The Pink Sheet Daily
January launch of long-awaited Office of Pharmaceutical Quality is part of broader Center reorganization that also includes new Office of Study Integrity and Surveillance.
You may also be interested in...
Another outside candidate is expected to eventually take over for the departing director Gregory Geba, and while the Office of Generic Drugs can run smoothly without a permanent leader for now, it cannot do so forever.
More than just a bureaucratic shell game, the promotion of the Office of Generic Drugs to “super office” status signals CDER Director Janet Woodcock’s tightened focus on generic drugs.
Warp Speed’s Slaoui predicts vaccinations starting within days of the 10 December advisory committee for Pfizer’s coronavirus vaccine. Regeneron’s monoclonal cocktail follows Lilly’s antibody product with an EUA.