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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 19

Medical Device Risk Management: Prepare for the Winds of Change

Feb 19

Outsourcing Facility Compounding: New Guidance for Outsourcing Facilities

Feb 20

FDA’s Plan for Modernizing the 510(k) Pathway: What Regulatory, Quality & Compliance Professionals…

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 26

Conducting Advanced Root Cause Analysis and CAPA Investigations

Editor's Picks

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Johnson

J&J Enters Robotic Surgery Market

The companies entered into a cooperative agreement in May 2018 to combine J&J’s NeuWave system with the Monarch platform.
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CDER’s Regulatory Modernization Will Peak in 2019, Woodcock Says

The center expects to have its proposed reorganization approved by HHS towards the end of FY 2019.

SHIONOGI RELEASES CARBAPENEM ANTIBIOTIC KIT

KEYWORDS Daily International Pharma Alert
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Shionogi has launched Finibax 0.25g IV Solution Kit, a kit for its proprietary antibiotic agent Finibax (doripenem hydrate). The new kit, which offers an antibiotic agent and solution together, simplifies the dissolution procedure, preventing medical errors.

JCN Network (http://www.japancorp.net/Article.Asp?Art_ID=12687)