Verisys

DECEMBER 12, 2023

– The best resource for monthly healthcare regulatory compliance updates. 01ER ): Effective as a permanent rule on 11/13/2023. 23 ): Effective on 1/14/2024, this amended rule has been updated to comply with specific requirement of §34-23-32 and the FDA Drug Supply Chain Security Act. Collaborative Practice ( 680-X-2-.44

Regulatory Compliance 52

Regulatory Compliance Compliance US Department of Health and Human Services Licensing 52

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Guidance for IRBs, Clinical Investigators, and Sponsors ” (“Final Guidance”), following the FDA’s earlier issuance of draft guidance on the subject in July 2014. study sponsor, regulatory agencies, etc.)

Informed Consent 40

Informed Consent FDA Compliance Regulatory Compliance 40

MedTrainer

JUNE 5, 2023

After years in limbo, USP <800> compliance will be required, effective November 1, 2023. It’s the first USP standard that’s enforceable by State Boards of Pharmacy, OSHA, and the FDA. Provide training for staff USP <800> clearly states that everyone who handles hazardous drugs must understand the requirements.

Compliance 52

Compliance FDA Regulatory Compliance Hospitals 52

SQA

OCTOBER 18, 2022

Policymakers, regulators, and legislators should not make any decisions that impact consumers’ access to FDA-approved sunscreen UV filters until the scientific community reaches an informed consensus. PIC/S Sub-Committees have been elected for a two-year term starting on 01 January 2022 and ending on 31 December 2023.

US Department of Health and Human Services 40

US Department of Health and Human Services FDA COVID-19 Compliance 40

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.

FDA 105

FDA US Department of Health and Human Services COVID-19 Informed Consent 105

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).

Informed Consent 59

Informed Consent Malpractice FDA Regulatory Compliance 59

Drug & Device Law

JUNE 5, 2023

2023 WL 2565853 (N.D. March 17, 2023), reconsideration denied , 2023 WL 3032063 (N.D. Kelley was actually decided a couple of months ago, but due to Reed Smith’s involvement in the case, we could not blog about it until the matter recently settled. 2023 WL 3032063, at *2 (N.D. citation omitted). footnote omitted).

FDA 59

FDA Regulatory Compliance Compliance Fraud 59