PMS (postmarket surveillance) key focus in CDRH (Center for Devices and Radiological Health) guidance document plans
This article was originally published in Clinica
Based on its list of guidance documents under development, the FDA's device centre (CDRH) has charted an ambitious workplan over the next 12 months. Most of the items included in the agency's annual guidance document agenda published yesterday are highly product specific.
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.