Global Medtech Guidance Tracker: December 2018
Executive Summary
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Twenty-three new guidance documents have been posted on the tracker since its last update.
You may also be interested in...
Breakthrough Pathway Final Guidance Eases Sponsor-Regulator Interaction Requirements
US FDA issued a final guidance that sets out requirements for its new Breakthrough Devices Program mandated by Congress. Under the new program, which replaces the Expedited Access Pathway, sponsors have more certainty about how quickly they will get responses from the agency and fewer requirements when setting up early interactions.
WHO Examines Ethical Criteria For Human Challenge Trials Ahead Of Next Health Emergency
The World Health Organization is looking to finalize its guidance on the ethical criteria that should be applied to studies that involve deliberately infecting healthy individuals to speed up research.
EU Consults On What Constitutes Personal & Commercially Confidential Data In Marketing Applications
Based on their experience with dealing with requests for access to documents over the past 12 years, EU regulators have proposed updating their guideline that provides for a harmonized approach to protecting personal data and business secrets in marketing authorization applications.