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 Compliance Clinical Trials Compliance Trials 52

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

The FDA compliance data, sorted by category, shows there were 159 Warning Letters issued to drug manufacturers or sponsors during 2023, with 161 issued in calendar year 2022. Summaries of the most striking recently released Warning Letters are included below.

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FDA Clinical Trials FDA Compliance Production 57

Drug & Device Law

MARCH 19, 2024

And while the court agreed that placing a product into the stream of commerce is not enough to be “purposeful availment,” the manufacturer here did more.

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FDA FDA Compliance Trials FDA Approval 52

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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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.

Compliance 52

Compliance FDA Compliance FDA Clinical Trials 52

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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Compliance Government FDA Compliance Production 52