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

FDA Law Blog: Biosimilars

JANUARY 1, 2024

Maybe that’s also why FDA last week publicized the highest number of important Warning Letters of the year (compared with prior releases in 2023). Perhaps FDA wanted us to remember 2023 as the year FDA succeeded in uncovering critical defects in drug and device manufacturing, and in critical trials. Dextrum Laboratories Inc.

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. We haven’t seen standards compliance litigated, but T.M. Janssen Pharmaceuticals, Inc. , 3d 1245 (N.J. E.g. , Commonwealth v.

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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