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

Maybe that’s also why FDA last week publicized the highest number of important Warning Letters of the year (compared with prior releases in 2023). 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.

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Drug & Device Law

JANUARY 25, 2024

In Watson , even though it was about FTC regulation, the Court took a shot at the notion that drug and device companies might try to remove their myriad product liability cases based on this statute if interpreted to cover mere regulation. 308 (2005), which comes up not infrequently in drug and device product liability cases.

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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. , but see Hahn v. Richter , 543 Pa. 558, 673 A.2d Tincher , 104 A.3d

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Drug & Device Law

MARCH 19, 2024

Plaintiff’s primary allegation is that the clips have a migration rate higher than what was reported to the FDA. Since the clips are PMA, the first prong is met—PMA devices have specific FDA requirements. Plaintiff did not allege that the design of the clips deviated from the FDA approved design.

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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. which caused the claimant’s harm was subject to premarket approval or licensure by the federal Food and Drug Administration. . .

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