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Simplifying Global Compliance
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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.
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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Solasia Pharma’s Episil Pain Relief Device Approved in Korea
According to clinical results, the device quickly provides oral pain relief and physical protection that lasts up to eight hours.
Federal Court Rules Against Sun Pharmaceuticals in Oracea Patent Dispute
The judge said the company failed to prove the patents’ obviousness with “clear and convincing evidence.”
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