FDA Compliance and Pharmaceuticals - Drug Discovery Digest

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FDA Compliance

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 FDA Compliance Clinical Trials Production

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

Drug & Device Law

JANUARY 15, 2024

We have discussed how exclusion of FDA compliance in pelvic mesh cases, based on a false equivalence between preemption and evidentiary admissibility, has hampered the defense in that litigation. A plaintiff’s pursuit of such theories thus should allow admission of standards compliance evidence. Janssen Pharmaceuticals, Inc. ,

Compliance

Compliance Government FDA Compliance Production

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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