Health Law Advisor
SEPTEMBER 5, 2023
On August 15, 2023, the U.S. Food and Drug Administration (“FDA”) released final guidance on informed consent for clinical investigations (“Final Guidance”). This update follows FDA’s draft guidance, which was issued in July 2014, and supersedes the FDA’s “A Guide to Informed Consent,” which was issued in September 1998.
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Guidance for IRBs, Clinical Investigators, and Sponsors ” (“Final Guidance”), following the FDA’s earlier issuance of draft guidance on the subject in July 2014.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to accelerate the adoption of digital health technologies, the U.S. Food and Drug Administration (“FDA”) released draft guidance regarding the conduct of decentralized clinical trials (“DCTs”) for drugs, biological products and devices.
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.
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.
Healthcare IT Today
JUNE 13, 2024
Data security also remains a pervasive worry, with insufficient reassurance to allay fears of breaches or unauthorized access to sensitive patient information. Enhancing the interpretability of AI models and promoting informed consent empower patients to understand and control how their data is used in AI applications.
Hall Render
FEBRUARY 10, 2023
Physicians not returning Casper resident, needing surgery, may have to go elsewhere Column: Sheridan Memorial Hospital’s cardiac cath lab earns national accreditation The post Health Provider News – February 10, 2023 appeared first on Law Firm | Health Care Law Firm in the USA | Hall Render. Blue Shield of California is counting on it.
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