Healthcare IT Today

JANUARY 8, 2024

The excitement around new tools took hold of all industries in 2023, and the potential is expansive. In 2023, Pear Therapeutics filed for bankruptcy and Akili abandoned the prescription business model. They will continue to run clinical trials to confirm their claims and value proposition but will not seek FDA approvals.

Pharmaceutical Industry 110

Pharmaceutical Industry Due Diligence Compliance Regulatory Compliance 110

Bill of Health

APRIL 4, 2024

Although the cross-sectoral AI legislation that is now introduced by the European Commission’s Digital Strategy aims to be integrated with existing sectoral legislation such as the MDR, the IVDR and the Machinery Directive, it is uncertain how overlapping regulatory compliance requirements for AI-driven medical devices will be managed in practice.

FDA 282

FDA Regulatory Compliance Malpractice Health Insurance 282

Dot Compliance

JANUARY 20, 2023

With 95% of life sciences executives surveyed saying the development of innovative products is their focus for 2023, quality management will be a top priority to reduce risks and costs, increase regulatory compliance, and accelerate the product development lifecycle.

Regulatory Compliance 52

Regulatory Compliance Compliance FDA 52

Healthcare IT Today

DECEMBER 28, 2023

As a result, companies are grappling with how to maintain quality assurance and regulatory compliance as more frequent software updates are required and software complexity grows. In building out its solutions, Ketryx spent years designing products around FDA regulations and quality standards. Learn more at ketryx.com.

FDA 115

FDA Regulatory Compliance Compliance 115

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 COVID-19 Vaccine 105

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.,

Medicare 52

Medicare Medicare FDA Regulatory Compliance 52

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. Finally, Defendant argues that Georgia law permits regulatory compliance to generally rebut the high willfulness requirement for punitive damages. 2023 WL 3032063, at *2 (N.D. The Kelley court agreed with the defendant.

FDA 59

FDA Regulatory Compliance Compliance Fraud 59