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

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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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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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

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. A plaintiff’s pursuit of such theories thus should allow admission of standards compliance evidence. Ethicon, Inc. , 3d 1245 (N.J.

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Drug & Device Law

JULY 26, 2023

470 (1996), outside of the (now obsolete) presumption against preemption context in which it occurred − making FDA compliance an all-or-nothing proposition in medical device cases. In pre-market approval cases, FDA compliance is controlling − a ground for preemption − so courts and juries never try those cases.

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