2005, FDA Compliance and Regulations

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2005

FDA Compliance

Regulations

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

Federal Officer Removal Fails In California

Drug & Device Law

JANUARY 25, 2024

142 (2007), mere regulation of the product or conduct at issue—the medical walker is a non-prescription, Class I medical device with general controls only—is not a basis for removal under this statute. 308 (2005), which comes up not infrequently in drug and device product liability cases. Since the Supreme Court decision in Watson v.

Production

Production Regulations FDA Compliance Compliance

Drug Discovery Digest

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

Federal Officer Removal Fails In California

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