US FDA to hold workshop on nanomaterial-containing devices
This article was originally published in Clinica
Executive Summary
The US Food and Drug Administration plans to hold a public workshop on 23 September to gather information on the manufacturing, characterisation and biocompatibility evaluation of medical devices and diagnostics that contain or use nanomaterials and nanostructures.
You may also be interested in...
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.
Global Pharma Guidance Tracker – March 2024
Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.