Sweeping FDA Cuts Hit CDRH Staffer’s Inboxes

By MedTech Intelligence Staff

On February 15, numerous probationary staff at FDA began receiving emails notifying them they had been fired. “Unfortunately, the Agency finds that you are not fit for continued employment because your ability, knowledge and skills do not fit the Agency’s current needs, and your performance has not been adequate to justify further employment at the Agency,” said the letters.

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Taking the Headache out of Maintaining 21 CFR Compliance

By Bryan Christiansen

Overcoming 21 CFR compliance challenges – stringent equipment maintenance requirements, overwhelming documentation demands, the need to maintain data integrity. Insights into challenges healthcare organizations face with compliance and how to incorporate new tools and processes for streamlining maintenance processes, reducing compliance burdens, and ensuring the highest standards of safety and efficiency.

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Captis Ask the Expert
Captis Ask the Expert

AI and Automation Tools:
Medical Writers’ Point of View

By Celegence

EU MDR and IVDR have created many new challenges for medical writing and regulatory affairs professionals. An increased workload, combined with the scarcity of expert resources, makes it essential to find innovative solutions that maintain efficiency and prevent burnout among highly skilled teams. How does use of technology help? AI-driven tools and automations enhance productivity,…

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