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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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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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

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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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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