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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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The Future of Generic Drug Competition: Deconstructing FDA and Congressional Initiatives

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The Age of eSource: Modernizing Clinical Trials

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Pharma Regulation in 2020: FDA Priorities in the Upcoming Election Year

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Implement a Best Practice Medical Device Change Control Process: Avoid Common Pitfalls

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Master the Regulatory Pathway for Cell & Gene Therapy Submissions: Strategies for Successful BLAs

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Texas Device Manufacturer, Sterilizer Draws FDA Warning Letter

The process challenge packs used for sterilization did not represent the facility’s routinely sterilized components, the agency said.
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SK Life Science’s XCOPRI Approved for New Treatment for Adults With Partial-Onset Seizures

The company is expected to make the drug available in the second quarter of 2020.
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