Clinical Trials, FDA Compliance and Pharmaceuticals

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

FDA Law Blog: Biosimilars

JANUARY 1, 2024

If FDA wanted to create that impression, it likely succeeded. Warning Letters, generally made public in a batch each Tuesday, are FDA’s public sanction that is most widely used to bring pressure on manufacturers and clinical trial investigators. They have great impact on most companies that receive them.

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

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

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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