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 59

Manufacturing Production Drugs Contract Manufacturing 59

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 52

Compliance Manufacturing Regulation Marketing 52

FDA Law Blog

JUNE 9, 2021

Koblitz — While typically, FDA is responsible for setting forth its own agenda and enforcing compliance with its own regulations, the Trump Administration’s HHS, on its way out the door in late 2020 , took the unusual steps of withdrawing an important FDA Compliance Policy Guide, “Marketed Unapproved Drugs – Compliance Policy Guide Sec.

Compliance 52

Compliance Drugs Production Marketing 52