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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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Dialogue’s Triage Support Technology Earns CE Mark

Artificial intelligence is “an important asset to reduce human bias when medical professionals triage patients in emergency rooms,” the company said.
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Woodcock to Congress: U.S. Must Revamp Manufacturing to Spur API Production

Only 28 percent of facilities making APIs for the U.S. market are domestic.

BANYU PHARMACEUTICAL ANNOUNCES SUBANALYSIS OF J-LIT, LARGE-SCALE CLINICAL TRIALS OF ANTI-HYPERLIPIDEMIC AGENT LIPOVAS

KEYWORDS Daily International Pharma Alert
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Banyu Pharmaceutical recently published the results of the Japan Lipid Intervention Trial (J-LIT), large-scale clinical trials of LIPOVAS, its proprietary anti-hyperlipidemic agent, in Circulation Journal, an academic and professional publication of the Japanese Circulation Society.

JCN Network (http://www.japancorp.net/Article.Asp?Art_ID=12768)