Hall Render

OCTOBER 5, 2023

On August 15, 2023, the U.S. Food and Drug Administration (“FDA”) finalized “ Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors ” (“Final Guidance”), following the FDA’s earlier issuance of draft guidance on the subject in July 2014.

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Hall Render

SEPTEMBER 14, 2023

On May 2, 2023, in a move intended to accelerate the adoption of digital health technologies, the U.S. Food and Drug Administration (“FDA”) released draft guidance regarding the conduct of decentralized clinical trials (“DCTs”) for drugs, biological products and devices.

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SQA

FEBRUARY 15, 2023

Following the draft consultation in November 2022, the NMPA announced the issuance of the Regulations on the Supervision and Management of Enterprises Implementing the Main Responsibility of the Quality and Safety of Medical Devices , which will come into force on 01 March 2023.

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Healthcare Law Blog

AUGUST 9, 2023

April 7, 2023, Texas District Court Judge Matthew Kacsmaryk granted the Alliance for Hippocratic Medicine’s request for a preliminary injunction to block the FDA’s approval of Mifepristone during litigation. [1] 1] On April 21, 2023, the U.S. 345 on May 31, 2023, to bolster abortion rights. 5 into law. 5 into law.

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Drug & Device Law

DECEMBER 29, 2023

In 2023 there seemed to be an unusually large number of other decisions that are likely to have a substantial impact on what we or our clients do, but involve either different products, non-product claims, or both. In 2023, these include United States ex rel. 2023) (no medical monitoring in Delaware) ( here ); Brown v.

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Drug & Device Law

APRIL 21, 2023

84075, 2023 WL 2779206 (Nev. 4, 2023), and while the opinion does not disclose whether the implants were 3D printed, the opinion raises all the same questions. The FDA regulates medical devices, including 3d-printed medical devices when made by medical device manufacturers (see here for more information).

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