Global Medtech Guidance Tracker: December 2022
Executive Summary
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Forty-nine documents have been posted on the tracker since its last update.
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EU Guidance On Periodic Safety Update Reports: Mixed Reactions
Periodic safety update reports are a key feature of the EU’s Medical Device Regulation. New guidance is intended to support manufacturers in understanding these requirements. But there is some confusion over timelines.
Human Factors Guidance Provides Clarity On Data Necessary In Premarket Submissions
FDA released an updated human factors guidance document on 9 December clarifying the types of human factor data the agency wants to see in pre-market submissions.
EMA Says Yes To BMS’ Sotyktu But Turns Down Ipsen’s Sohonos
The European Medicines Agency has recommended pan-EU marketing approval for four medicines but turned down Ipsen’s treatment for an ultra-rare bone disorder. It has also OK’d new uses of seven already-approved drugs and is reviewing efficacy concerns regarding Novartis’ sickle cell medicine.