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 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.

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H1 Blog

AUGUST 30, 2023

Prove & Facilitate HIPAA & FDA Compliance Another facet of healthcare cloud technology that could impact sales is compliance with HIPAA and FDA regulations.

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Compliance FDA Compliance FDA Regulations 52

Drug & Device Law

MARCH 19, 2024

TBI was the first nationwide (or close to it) analysis of whether a given jurisdiction permitted, under state law, a “warning”-based cause of action against a manufacturer of an FDA-regulated prescription drug or medical device for allegedly failing to report adverse events to the FDA.

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FDA FDA Compliance Trials FDA Approval 52

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. In those cases , the question is often whether the claims put FDA compliance at issue or whether the defenses do.

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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.

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Compliance Government Production FDA Compliance 52

Drug & Device Law

JULY 26, 2023

So plaintiffs will not be able to hide the truth of FDA regulation from the jury on retrial, while misleading the jury, nor try the same trick in any other pelvic mesh case in New Jersey going forward. pursuant to conditions established by the federal Food and Drug Administration and applicable regulations, including. . .

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