News & Analysis as of

Clinical Trials Policies and Procedures

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 18, Number 10. In This Month’s E-News: October 2021

Report on Research Compliance 18, no. 10 (October, 2021) - An audit by the HHS Office of Inspector General (OIG) of the National Human Genome Research Institute’s (NHGRI) pre-award risk assessment process concluded that...more

McDermott Will & Emery

CNIL Issues Provisional Recommendations for Remote Quality Control of Clinical Trials During the Health Crisis

Given the challenges of conducting clinical trials during the COVID-19 pandemic, many countries — including France — have allowed for some use of remote quality controls. In response to guidelines issued recently by European...more

Faegre Drinker Biddle & Reath LLP

FDA Issues Guidance on Conduct of Clinical Trials of Medical Products During COVID-19 Pandemic

As the COVID-19 pandemic continues to alter ways of life across the globe, clinical trials must be adapted for participant safety while maintaining accuracy in the midst of the ongoing crisis. In September 2020, the U.S. Food...more

Goodwin

Conduct of Clinical Trials During the COVID-19 Pandemic: Recommendations from FDA

Goodwin on

As the COVID-19 pandemic unfolds, our drug, biologic, and medical device clients conducting or planning to conduct clinical trials may be faced with challenges related to quarantines, travel limitations, site closures or...more

Bass, Berry & Sims PLC

How Should Institutions Conducting Research Respond to COVID-19?

Bass, Berry & Sims PLC on

As healthcare providers and universities respond to the spread of COVID-19, legal counsel at these institutions should be prepared to assist their institution’s research enterprise in anticipating and reacting to any changes...more

Holland & Knight LLP

FDA Announces New Policies to Advance Cell and Gene Therapies

Holland & Knight LLP on

On Jan. 15, 2019, Food and Drug Administration (FDA) Commissioner Scott Gottlieb and Center for Biologics Evaluation and Research (CBER) Director Peter Marks issued a statement proposing policies to support cell and gene...more

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