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Compliance

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Pharmaceuticals

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

FDA Law Blog: Biosimilars

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).

FDA

FDA Clinical Trials FDA Compliance Production

Dealing with the Pennsylvania Supreme Court’s Non-Decision on Standards Compliance Evidence

Drug & Device Law

JANUARY 15, 2024

That is significant because, unlike (now) every other state in the country, since 1987 Pennsylvania precedent prohibited defendants from introducing evidence of their compliance with government and/or industry standards (“standards compliance” or “compliance” evidence, for short) in strict liability design defect cases – generally.

Compliance

Compliance Government FDA Compliance Production

Drug Discovery Digest

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

Dealing with the Pennsylvania Supreme Court’s Non-Decision on Standards Compliance Evidence

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