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. FDA stated that the firm received 96 U.S. Summaries of the most striking recently released Warning Letters are included below. Dextrum Laboratories Inc.

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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

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. 2d 521 (Pa. Ethicon, 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.

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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.” A §510(k) device might not be “approved” by the FDA, but it is certainly “licensed” so that it can be marketed. 2023 WL 4714042, at *15, see id.

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