Following in the footsteps of the other review programs at the US Food and Drug Administration's (FDA) Office ... outcome of the validation exercise and plan for process monitoring (Fig.

This training on FDA software validation and verification will provide you the best practices necessary to ensure that all systems are validated in compliance with FDA regulations. This webinar ...

Nyxoah is actively addressing one remaining item before FDA approval may be granted which is the validation of one process used with a component of the Genio system at its U.S. manufacturing site.

process validation, part and device traceability, along with the applicable quality management systems. Imricor is executing ...

The FDA’s latest draft guidance on accelerated approval for new drugs, “Expedited Program for Serious Conditions—Accelerated Approval of Drugs and Biologics,” is a game-changer for biopharmaceutical ...

The "How to Write Effective Standard Operating Procedures (SOPs) and Other Process Documents" training has been added to ResearchAndMarkets.com's offering. Standard Operating Procedures (SOPs) are ...

In a regulatory filing, DexCom (DXCM) disclosed that on March 4, the company received a warning letter from the U.S. FDA following inspections ... 483 and is in the process of preparing a written ...

Arlington, VA, March 26, 2025 (GLOBE NEWSWIRE) -- AAMI is pleased to announce that the FDA has amended ... of TIR106 is a welcome validation of AAMI’s efforts to promote patient well-being through the ...