Testicular implant PMAs
This article was originally published in The Gray Sheet
Executive Summary
FDA proposes calling for premarket approval applications for testicular prostheses in a Jan. 13 Federal Register notice ("The Gray Sheet" Jan. 11, p. 5). Comments on the proposal should be filed with the agency by March 15....
You may also be interested in...
Investors Go Beserk For Viking, Putting It Top Of Q1 Winners
The top 10 biggest share price winners and losers in Q1 from Evaluate show the investor frenzy for obesity drugs continues, while companies with governance doubts see shareholders retreat.
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.
Industry & Regulators To Align Advice on COVID-19 Vaccine Updates
A multi-stakeholder workshop looked at the data needed to support updates to vaccine composition and the time required by manufacturers to update their vaccines, change their manufacturing processes and prepare approval applications.