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Life Sciences New Guidance Compliance

Health Care Compliance Association (HCCA)

HHS OIG General Compliance Program Guidance: An empowered and independent compliance function

Corporate Compliance & Ethics Week 2023 kicked off with a gift for healthcare and life sciences compliance practitioners by way of the U.S. Department of Health and Human Services (HHS) Office of Inspector General’s (OIG)...more

Goodwin

A Practical Look at OIG’s New Compliance Guidance

Goodwin on

On November 6, 2023, for the first time in 15 years, HHS OIG issued a new reference guide for the health care compliance community – the General Compliance Program Guidance, or GCPG. While the GCPG does not set new legal...more

Akin Gump Strauss Hauer & Feld LLP

Life Sciences Regulators Must Write Cloud-Specific Guidance

Cloud services have revolutionized the way businesses and governments operate, offering scalability, flexibility, cost-efficiency and security. This is especially the case in the life sciences industry, where the cloud has...more

Health Care Compliance Association (HCCA)

‘No More Boutique Studies’: NIH Mulls ‘Stopping Rules,’ Other Changes to Improve Clinical Trials

At some point in the future, NIH may halt funding for clinical trials deemed too underpowered to produce meaningful findings or that fail to meet enrollment goals. To do this, the agency would have to adopt so-called...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 17, Number 9. In This Month's E-News: September 2020

Report on Research Compliance 17, no. 9 (August 20, 2020) - The Office of Management and Budget has published guidance for agencies and recipients of federal awards and contracts, finalizing a document issued in February...more

Akin Gump Strauss Hauer & Feld LLP

[Podcast] DOJ’s New Guidance on Evaluating Compliance Programs: What You Need to Know

In this episode, Akin Gump health care and life sciences counsel Taylor Jones and Matt Wetzel discuss the Justice Department’s recent guidance on evaluation of corporate compliance programs. Among the topics covered: •...more

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