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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H1 Blog

AUGUST 30, 2023

billion in 2018 to $44.932 billion by 2023, a CAGR of 18.2 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

2021), aff’d by an equally divided court , 2023 WL 8859656 (Pa. 22, 2023) (“ Sullivan I ”), another decision not involving prescription medical products. 2023 WL 8859656, at *9 (Pa. 22, 2023) (Opinion Announcing the Judgment of the Court (“OAJC”)). OAJC, 2023 WL 8859656, at *11. Werner Co. , 3d 730 (Pa.

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Drug & Device Law

JANUARY 25, 2024

23-cv-01060-AJB-DDL, 2023 WL 9010545 (S.D. 15, 2023), a California plaintiff alleged that the medical walker he purchased broke, causing him to fall and sustain injury. In those cases , the question is often whether the claims put FDA compliance at issue or whether the defenses do. In Rubalcava v. Medline Indus.,

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Drug & Device Law

JULY 26, 2023

3d , 2023 WL 4714042 (N.J. July 25, 2023) (which should really be captioned “ McGinnis ” because plaintiff Hrymoc settled, see n.1). Hrymoc , 2023 WL 4714042, at *12-13. 22, 2015) (admitting §510(k) compliance in pelvic mesh case under North Carolina law). 2023 WL 4714042, at *15, see id. Ethicon, Inc. ,

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