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As the Calendar Turns, Cybersecurity Remains Key Focus of Digital Health Enforcement

FDA Law Blog

JANUARY 5, 2023

To date, regulatory enforcement litigation focused on actual or imminent patient harm has taken a backseat to cybersecurity as FDA continues to update and implement its oversight framework. Combination products might be part drug, part device, or part software or hardware.

Manufacturing

Manufacturing Patient-Centered Provider Telehealth

OTAT Town Hall on Cell Therapy CMC – The Recording is Available but Here’s an Appetizer

FDA Law Blog

JANUARY 4, 2023

Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and controls (CMC). By Holly N.

Manufacturing

Manufacturing Engineering Clinic Provider

Primary Care Digest

As the Calendar Turns, Cybersecurity Remains Key Focus of Digital Health Enforcement

OTAT Town Hall on Cell Therapy CMC – The Recording is Available but Here’s an Appetizer

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