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. Dextrum Laboratories Inc.

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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. You must also meet all FDA requirements for device security, both premarket and postmarket , to minimize risks to cybersecurity.

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Drug & Device Law

JANUARY 25, 2024

In those cases , the question is often whether the claims put FDA compliance at issue or whether the defenses do. Complaints are routinely written to omit mentions of FDA, the FDCA, and regulatory compliance to avoid both preemption and federal question removal. Darue Eng’g & Mfg. ,

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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. In state court, Creazzo remains binding precedent. 3d 1245 (N.J.

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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. A §510(k) device might not be “approved” by the FDA, but it is certainly “licensed” so that it can be marketed. Lohr , 518 U.S.

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