Warning Letter Roundup & Recap – April 18, 2017
An Abbott plant manufacturing St. Jude Medical cardiac products was slapped with a warning for quality systems issues in the only warning letter released the week of April 18.
You may also be interested in...
Submission surge in late 2019 means a spike in late summer 2020 user fee goals, including 16 novel agents in August alone.
Keeping Track: Approvals For Tazverik And Tepezza, Priority Reviews For Belantamab Mafodotin And Lynparza
The latest drug development news and highlights from our US FDA Performance Tracker.
Accelerated approval in epithelial sarcoma may de-risk the firm’s goals for approval of Tazverik in follicular lymphoma and other larger indications.