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Health Care Compliance Association (HCCA)

In This Month’s E-News: February 2024

The Food and Drug Administration (FDA) is seeking strategies from Jeffrey W. Taub, M.D., to prevent future violations of human subject regulations the agency said were documented during site visits in September and October...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: January 2024

The Department of Commerce and the National Institute of Standards and Technology are requesting comments on a “draft guidance framework designed to help federal agencies evaluate when it may be appropriate to exercise...more

Foley & Lardner LLP

Protecting Innovations in SaMD & Biomedical Applications

Foley & Lardner LLP on

With the ever-growing adaptation of software in all realms of health care, the market for software for medical devices (SaMD) is forecasted to grow 16.7% per year over the next decade and surpass $5 billion by 2032....more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 20, Number 1. With Greater Than Half Its Positions Vacant, OHRP Employing More Technology,...

The HHS Office for Human Research Protections (OHRP) is currently operating with a 62% vacancy rate among staff, as it has not filled open positions, agency officials say. OHRP has a staff of 20, but there are an additional...more

White & Case LLP

Healthcare M&A on track to set new record in 2021

White & Case LLP on

Heightened interest in medical suppliers, contract research organizations and biotech firms resulted in an impressive year for healthcare dealmaking- Dealmaking within the pharma, medical and biotech sector continued from...more

McDermott Will & Emery

HHS Releases Draft Federal Health IT Strategic Plan for 2020-2025

The Department of Health and Human Services released its draft 2020-2025 Federal Health IT Strategic Plan for public comment. This article outlines the goals of the plan, as well as challenges in healthcare that ONC hopes the...more

Foley & Lardner LLP

Privacy Issues in the Sharing of Genetic Information

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Scientific breakthroughs and technological advancements have led to the emergence of personalized medicine — a practice based on the use of an individual's genetic profile to guide health care decisions made about the...more

Bergeson & Campbell, P.C.

IARC Advisory Group Recommends Multi-Walled Carbon Nanotubes as High Priority

An International Agency for Research on Cancer (IARC) Advisory Group met on April 7-9, 2014, to recommend priorities for IARC Monographs during 2015-2019. The Advisory Group assessed the responses to a call for nominations...more

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