Generic Drugs Office Becomes Super; Safety Organizational Challenges Remain
This article was originally published in The Pink Sheet Daily
About 200 reviewers are left behind in the restructuring as CDER Director Woodcock lays the groundwork for the Office of Pharmaceutical Quality.
You may also be interested in...
FDA Proposes Unilateral Generic Drug Label Changes, Signaling End To Liability Shield
FDA proposed rule would allow ANDA holders to unilaterally make label changes prior to FDA’s approval; NDA and other ANDA holders would have 30 days to revise their labels once FDA approves the change.
REMS Modification Guidance Coming As FDA Rejects Petition For Shared REMS Rules
Agency will wait until it has more experience with shared REMS before deciding whether to issue regulations or guidance on their implementation, but for now it hopes sponsors can work out problems on their own.
Watson’s Bupropion XL Undone By Outlier Patient, Bankrupt CRO
After long delay, FDA quietly reveals second Wellbutrin generic deemed not therapeutically equivalent; ex-Office of Generic Drugs official predicts FDA will tighten criteria for extrapolating data to higher generic strengths.