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Research and Development › Pharmaceutical Industry › Compliance

Gardner Law

Why Compliance Audits Are Non-Negotiable

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In today’s heightened enforcement environment, compliance auditing isn’t just a best practice—it’s a necessity. Federal and state laws and industry guidance, including the Office of Inspector General (OIG) Compliance Program...more

Husch Blackwell LLP

Navigating Clinical Research Agreements and Regulatory Strategy for Successful Commercialization

Husch Blackwell LLP on

Clinical research agreements (CRAs) and developing a regulatory strategy—particularly in connection with the Food and Drug Administration (FDA)—are crucial for a company’s ability to bring innovative life sciences products to...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: August 2024

Health Care Compliance Association (HCCA) on

The Food and Drug Administration (FDA) has given Massachusetts Institute of Technology (MIT) 15 days from receipt of its June 21 warning letter to elaborate on corrective actions to address violations of federal requirements...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q1 2024 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

Health Care Compliance Association (HCCA)

[Virtual Event] Research Compliance Conference - November 9th, 8:00 am - 5:00 pm CT

Health Care Compliance Association (HCCA) on

Get the latest strategies and insights for healthcare research compliance - Whether you missed this year’s in-person Research Compliance Conference or are looking for additional insights from research colleagues and...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 18, Number 7. In This Month’s E-News: July 2021

Health Care Compliance Association (HCCA) on

Report on Research Compliance 18, no. 7 (July 2021) - In a review of more than 500 NIH awards, the HHS Office of Inspector General (OIG) found that about one-fifth were funded “out of rank order,” and for more than a...more

Health Care Compliance Association (HCCA)

Report on Research Compliance 17, no. 7 In This Month's E-News: July 2020

Health Care Compliance Association (HCCA) on

Report on Research Compliance 17, no. 7 (July 2020) - NIH has opened its “initial data set and tools” in its All of Us research program to investigators under a new beta model that does not allow downloading of...more

Baker Donelson

Update on Regulatory Compliance in the Global Health Care Industry

Baker Donelson on

A comprehensive understanding of the constantly evolving layers that make up federal anti-corruption statutes, sanctions regulations and export control restrictions is imperative for both the pharmaceutical and health care...more

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