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.

FDA Compliance 52

FDA Compliance Clinical Trials Compliance FDA 52

FDA Law Blog: Biosimilars

JANUARY 1, 2024

Perhaps FDA wanted us to remember 2023 as the year FDA succeeded in uncovering critical defects in drug and device manufacturing, and in critical trials. If FDA wanted to create that impression, it likely succeeded. They have great impact on most companies that receive them.

FDA 59

FDA FDA Compliance Clinical Trials Production 59

Drug & Device Law

JANUARY 15, 2024

2006) – a precedential holding that the same Pennsylvania rule barring strict liability claims against prescription drugs also applied to prescription medical devices − should not be followed because the plaintiffs in Creazzo were supposedly “pro se.” Medtronic, Inc. , Sullivan , Donohue Concurrence in the result, 2023 WL 8859656, at *13.

Compliance 52

Compliance Government FDA Compliance Production 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. at 1228 (emphasis added).

FDA 52

FDA FDA Compliance FDA Approval Production 52

Drug & Device Law

JULY 26, 2023

From a bottom-line perspective, the most significant result was that evidence of the product’s 510(k) clearance was improperly excluded, requiring vacation of the verdict and a new trial. North Carolina law rejects strict liability altogether. So do a number of other jurisdictions, including Pennsylvania in prescription medical product cases.

Compliance 52

Compliance FDA Compliance FDA Clinical Trials 52