2005, Compliance and FDA Compliance - Drug Discovery Digest

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2005

Compliance

FDA Compliance

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

Drug & Device Law

JANUARY 15, 2024

That is significant because, unlike (now) every other state in the country, since 1987 Pennsylvania precedent prohibited defendants from introducing evidence of their compliance with government and/or industry standards (“standards compliance” or “compliance” evidence, for short) in strict liability design defect cases – generally.

Compliance

Compliance Government FDA Compliance Production

Federal Officer Removal Fails In California

Drug & Device Law

JANUARY 25, 2024

308 (2005), which comes up not infrequently in drug and device product liability cases. In those cases , the question is often whether the claims put FDA compliance at issue or whether the defenses do. Darue Eng’g & Mfg. ,

Production

Production Regulations FDA Compliance Compliance

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

Federal Officer Removal Fails In California

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