Simplifying Global Compliance
Recommended Products
EU MDR Compliance: A Checklist for Meeting Manufacturing, Safety and Performance Requirements
The FDAnews report EU MDR Compliance can help. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing.
Accelerating Generic Drug Development: The FDA’s New Plan for Increasing Generic Competition
Accelerating Generic Drug Development explains the FDA’s new policy and shows how to navigate the new pathway to approval.
Editor's Picks
Zimmer Biomet Recalls Robotic Surgery System
A single injury occurred out of the five complaints it received, the company said.
FDA Outlines New Fee Structure Under GDUFA II
The agency can collect backlog fees from holders of ANDAs that were pending on Oct. 1, 2012 and did not receive a tentative approval prior to that date.
Clinical Trials
Site or sponsor? We have everything you need to know to make your trial a success.
