FDA Law Blog: Biosimilars

JANUARY 1, 2024

Maybe that’s also why FDA last week publicized the highest number of important Warning Letters of the year (compared with prior releases in 2023). 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.

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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. Defendant] had submitted these reports to the FDA , but the trial justice limited their evidentiary use to the duty-to-warn and notice issues. Coopersurgical, Inc.

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Drug & Device Law

JANUARY 15, 2024

2006) – a precedential holding that the same Pennsylvania rule barring strict liability claims against prescription drugs also applied to prescription medical devices − should not be followed because the plaintiffs in Creazzo were supposedly “pro se.” Medtronic, Inc. , but see Hahn v. Richter , 543 Pa. 558, 673 A.2d Tincher , 104 A.3d

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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.” which caused the claimant’s harm was subject to premarket approval or licensure by the federal Food and Drug Administration. . . Lohr , 518 U.S.

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