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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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Feb 27

FDA Medical Device Compliance and Enforcement: Lessons from Last Year and Your Game Plan…

Mar 20

Medical Device Complaint Management: Escape the Labyrinth

Mar 21

FDA’s 2019 Medical Device Regulation Agenda: Are You Prepared

Mar 22

REMS Regulatory Developments and Best Practices

Mar 26

Conducting Advanced Root Cause Analysis and CAPA Investigations

Mar 27

ICH GCP E6 R2: Meeting CRO-Vendor Oversight Requirements

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NuVasive’s Magnetic Implant System Nabs Dual Clearance

The magnetic implant can treat defects in the tibia and femur caused by trauma or infection. 
Dr-reddys

Dr. Reddy’s Reports 11 Violations in FDA Inspection

Last September, the FDA found eight violations at a Dr. Reddy’s facility in Duvvada, Andhra Pradesh.

CURAGEN BEGINS SECOND CLINICAL TRIAL WITH VELAFERMIN

KEYWORDS Drug Pipeline Alert
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CuraGen has begun its second Phase II study of velafermin for the prevention of OM in cancer patients receiving high-dose chemotherapy, with or without radiotherapy, in the setting of autologous bone marrow transplantation.

CuraGen said that it expects the primary OM efficacy and safety results will be available by the third quarter of 2007, and the one year follow-up data will be available in the third quarter of 2008.