Containment, Contamination and FDA Compliance

FDA End-of-Year Release of Warning Letters Impresses (or Depresses)

FDA Law Blog

JANUARY 1, 2024

The FDA compliance data, sorted by category, shows there were 159 Warning Letters issued to drug manufacturers or sponsors during 2023, with 161 issued in calendar year 2022. Two device manufacturers received Warning Letters for QSR violations (QSR is FDA’s label for cGMP requirements applicable to medical device manufacturers).

Manufacturing

Manufacturing Production Drugs Contract Manufacturing

Comprehensive Guide to Medical Device Safety, Systems, and Regulatory Compliance: FAQ

Cloudbyz

AUGUST 19, 2024

Incident Response: Establishing a plan for responding to cybersecurity incidents, including detection, containment, eradication, and recovery. How does the FDA’s 510(k) clearance process work for medical devices? For example, the EU requires CE marking and compliance with the MDR, while the U.S. In the U.S.,

Compliance

Compliance Manufacturing Regulation Marketing

Clinical Research Informer

FDA End-of-Year Release of Warning Letters Impresses (or Depresses)

Comprehensive Guide to Medical Device Safety, Systems, and Regulatory Compliance: FAQ

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