US FDA misses deadline for submitting device user fee proposal to Congress
This article was originally published in Clinica
Executive Summary
The US Food and Drug Administration has missed its 15 January deadline for submitting a plan to Congress on how much user fees the medical device industry should pay the agency to evaluate its products in fiscal years 2013-2017.
You may also be interested in...
FDA, Industry To Miss MDUFA V Congressional Deadline; Insiders At Odds Over Future Of Deal
The US agency and the medtech industry still have significant disagreements, which means they will miss a 15 January deadline to send the MDUFA V user-fee deal to Congress. Insiders disagree, however, on how severe those disagreements are and when a deal can be reached.
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.