ProRelix Research

DECEMBER 28, 2023

Considering the crucial role that the information generated from clinical trials play in the approval of new drugs, biological, and medical devices, it is only logical that the data garnered […] The post Clinical Data Standardization in Clinical Trials: FDA Compliance in Clinical Data Management appeared first on ProRelix Research.

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FDA Compliance Clinical Trials Compliance Trials 52

FDA Law Blog: Biosimilars

JANUARY 1, 2024

If FDA wanted to create that impression, it likely succeeded. Warning Letters, generally made public in a batch each Tuesday, are FDA’s public sanction that is most widely used to bring pressure on manufacturers and clinical trial investigators. They have great impact on most companies that receive them.

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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.

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Compliance Government Production FDA Compliance 52

Drug & Device Law

JULY 26, 2023

At trial, plaintiffs not only attacked the defendant’s due care generally, they specifically assailed “the reasonableness of [the defendant’s] conduct in not performing clinical trials or studies.” In pre-market approval cases, FDA compliance is controlling − a ground for preemption − so courts and juries never try those cases.

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Compliance FDA Compliance FDA Clinical Trials 52