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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H1 Blog

AUGUST 30, 2023

MarketsandMarkets projects the global healthcare cloud computing market, with North America leading the way, will grow from $19.46 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

JANUARY 15, 2024

It is not evidence of the underlying attributes of the product that make it compliant with regulations or standards, which is presumably admissible subject to the ordinary Rules of Evidence. A plaintiff’s pursuit of such theories thus should allow admission of standards compliance evidence. Central Medical Health Services, Inc. ,

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Drug & Device Law

MARCH 19, 2024

It involves allegations against the manufacturer and distributor of surgical clips used in tubal ligation surgery—Class III Pre-Market Approved (“PMA”) medical devices. Coopersurgical, Inc. 2024 WL 1109055 (D.R.I. 14, 2024). Plaintiff had surgery in 2014 in which the clips were used. at 731, based on a pre- Riegel decision, Hodges v.

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Drug & Device Law

JULY 26, 2023

It was thus “unfair for the trial court not to allow [defendant] to explain in response that it received 510(k) clearance to market the devices without clinical studies or trials.” pursuant to conditions established by the federal Food and Drug Administration and applicable regulations, including. . . labeling regulations.

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