Innocoll Holdings Names New CEO

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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.

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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.

Events

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Aug 22

510(k) Change Analysis: Make the Guidance Documents Work for You

Aug 27

Preparing for a MDSAP Audit: A Case Study from the Manufacturer’s Perspective

Sep 4

Clinical Trial Risk and Performance Management Summit

Sep 10

EU-Medical Device Regulation/In Vitro Diagnostics Regulation Compliance Workshops

Sep 17

Regenerative Medicine and Stem Cell Regulation: What You Need to Know

Sep 19

Clarity on Clinical Investigations: What You Need to Know About EU-MDR and ISO/DIS 14155:2018

Editor's Picks

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FDA Clears Lumendi’s Single-Use Endoscopic Electrosurgical Knife

The product is able to administer a submucosal injection as tissue dissection is taking place in the digestive tract to create and maintain a fluid cushion.

FDA Collaboration Pulls RWE in Clinical Oncology Trials

Syapse’s oncology researchers will participate in the effort.