FDA Law Blog: Biosimilars

JANUARY 1, 2024

Perhaps FDA wanted us to remember 2023 as the year FDA succeeded in uncovering critical defects in drug and device manufacturing, and in critical trials. If FDA wanted to create that impression, it likely succeeded. FDA stated that the firm received 96 U.S. Dextrum Laboratories Inc. Terragene S.A.,

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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. We do not believe that the trial justice abused her discretion in so ruling. Coopersurgical, Inc. 2024 WL 1109055 (D.R.I. 14, 2024). at 1228 (emphasis added).

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Drug & Device Law

JANUARY 15, 2024

A fourth Justice concurred in the result, treating the issue of standards compliance in Sullivan as a matter of evidence, and holding that the lack of a sufficient trial record supporting the relevance of the specific standards at issue in Sullivan meant that the trial judge’s exclusion was not an abuse of discretion.

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Drug & Device Law

JULY 26, 2023

From a bottom-line perspective, the most significant result was that evidence of the product’s 510(k) clearance was improperly excluded, requiring vacation of the verdict and a new trial. North Carolina law rejects strict liability altogether. So do a number of other jurisdictions, including Pennsylvania in prescription medical product cases.

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