FDA Compliance, Pharmaceuticals and Regulations

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FDA Compliance

Pharmaceuticals

Regulations

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

FDA Law Blog: Biosimilars

JANUARY 1, 2024

Four of the letters addressed failure to comply with drug Current Good Manufacturing Practice regulations, four more stated that the recipients were distributing unapproved drug products, two alleged violations of the Quality System Regulation by medical device manufacturers, and one was addressed to a clinical investigator.

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

It is not evidence of the underlying attributes of the product that make it compliant with regulations or standards, which is presumably admissible subject to the ordinary Rules of Evidence. A plaintiff’s pursuit of such theories thus should allow admission of standards compliance evidence. An illustrative example is Hrymoc 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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