2005 and FDA Compliance - Drug Discovery Digest

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2005

FDA Compliance

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. Ethicon, Inc. , 3d 1245 (N.J.

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. This is not the same as federal question removal, as defined in Grable & Sons Metal Prods., 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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