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White & Case LLP

Life Science Private Equity Risk

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Private Equity focused on investment and operations within the Life Science industry faces significant compliance, operational and business risk due to the heavily regulated nature of the investment targets and portfolio...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,...

Health Care Compliance Association (HCCA) on

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

Bass, Berry & Sims PLC

New FDA Draft Guidance on Use of Digital Health Technologies in Clinical Trials

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On December 23, 2021, the United States Food and Drug Administration (FDA) announced the availability of a draft guidance for industry, investigators, and other stakeholders entitled “Digital Health Technologies for Remote...more

Lowenstein Sandler LLP

A Look Ahead: US FDA And Medical Device Regulations In 2021

Lowenstein Sandler LLP on

The pandemic year of 2020 presented FDA with many enormous challenges, including how to use emergency authorizations to approve diagnostic tests, personal protective equipment, and therapies, how to conduct remote...more

Troutman Pepper

Privacy And Data Security For Life Sciences And Health Care Companies

Troutman Pepper on

Pepper Hamilton Health Care-Life Sciences Webinar - The explosion of mobile technology and Web applications linking patients with doctors, pharmacies and medical devices is undergoing scrutiny by the FDA, FTC, HHS and...more

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