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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.

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Nov 12

A Patient-Centered Path to Clinical Trial Success

Nov 13

ICH E6 GCP Interactive Workshops

Nov 13

Conducting Advanced Root Cause Analysis and CAPA Investigations

Nov 14

PCORnet®, The National Patient-Centered Clinical Research Network

Nov 19

ICH E8 Developments: Are You Sure You’re Up to Date?

Nov 21

Understanding UDI in EU Device Regulations

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Zimmer Biomet Recalls Robotic Surgery System

A single injury occurred out of the five complaints it received, the company said.
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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.

BIOMIRA REPORTS LUNG CANCER DRUG STUDY RESULTS

KEYWORDS Drug Pipeline Alert
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Biomira has reported results from a clinical trial of its non-small cell lung cancer drug, Stimuvax.

The final survival results from an analysis of the Phase IIb data confirmed a median survival in patients with Stage IIIB cancer of 30.6 months with Stimuvax, while patients in the same stage who were in a control test group had a median survival of 13.3 months.