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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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

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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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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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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Production Regulations FDA Compliance Compliance 52

Drug & Device Law

JULY 26, 2023

In these states, product liability claims are brought as negligence actions based on the reasonableness of a defendant’s conduct, and a defendant’s compliance with applicable governmental standards is typically relevant evidence. 22, 2015) (admitting §510(k) compliance in pelvic mesh case under North Carolina law). See Winebarger v.

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Drug & Device Law

JANUARY 15, 2024

That is significant because, unlike (now) every other state in the country, since 1987 Pennsylvania precedent prohibited defendants from introducing evidence of their compliance with government and/or industry standards (“standards compliance” or “compliance” evidence, for short) in strict liability design defect cases – generally.

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