News & Analysis as of

Research and Development Clinical Trials Coronavirus/COVID-19

Maynard Nexsen

The Impact of COVID-19 on Clinical Research in the Life Sciences Industry: Is there a Silver Lining?

Maynard Nexsen on

Clinical research is one of the foundations of the Life Sciences industry as it involves the scientific investigation and treatment of diseases and other medical conditions in order to improve medical knowledge related to the...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 18, Number 9. In This Month’s E-News: September 2021

Report on Research Compliance 18, no. 9 (September, 2021) - A former Harvard Medical School and Massachusetts General Hospital (MGH) researcher who was the principal investigator on a 2014 NIH award of $939,495.27 and...more

Health Care Compliance Association (HCCA)

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

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)

[Virtual Event] 2021 Research Compliance Conference - June 14th - 16th, 9:00 am - 5:00 pm CDT

Attend HCCA’s annual Research Compliance Conference to receive the latest insights and guidance on emerging research compliance risks and solutions. This virtual event, held June 14 – 16, will be live and interactive. Learn...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 17, Number 12. In This Month's E-News: December 2020

Report on Research Compliance 17, no. 12 (December 2020) - Finalizing a document issued last year, on Nov. 9 the Food and Drug Administration issued “Enhancing the Diversity of Clinical Trial Populations—Eligibility...more

K&L Gates LLP

COVID-19: Frontline University Perspective on the Pandemic’s Disruption to Ongoing Research, and Public Policy Projections for a...

K&L Gates LLP on

In this episode, Rebecca Schaefer and Victoria Hamscho discuss the impact of the ongoing COVID-19 pandemic on university research programs and public policy projections for a potential federal response. The presenters are...more

Faegre Drinker Biddle & Reath LLP

What Is Involved in Clinical Trials and What Has Changed During COVID-19: A Brief Primer

Why Do Clinical Trials? Clinical trials are an important — and government-required — step on the way from an idea to a commercial medicinal product. All new pharmaceutical and biological products and most generic...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, October 2020 # 8

Hogan Lovells on

In Washington - Secretary Steven Mnuchin and Speaker Nancy Pelosi spoke for an hour Wednesday morning and plan to speak again tomorrow. Mnuchin says they continue to “make progress” while Pelosi’s spokesperson says the...more

Epstein Becker & Green

Product Launching in the Era of COVID-19 - Diagnosing Health Care Podcast

Epstein Becker & Green on

This Diagnosing Health Care episode looks at the adjustments to business operations and compliance programs that pharmaceutical and medical device companies need to consider as they launch new products during the ongoing...more

Morgan Lewis

FDA COVID-19 Guidance Roundup for Drug and Biologics

Morgan Lewis on

From the beginning of the coronavirus (COVID-19) pandemic, FDA actively provided guidance to members of the drug and biologic industries, including sponsors, investigators, pharmacies, and compounders....more

Orrick, Herrington & Sutcliffe LLP

Board Oversight of Clinical Trials During the Pendency of the COVID-19 Pandemic

COVID-19 has had far-reaching social, economic and regulatory impacts. Nearly all companies (private and public, large and small) have had reason to more frequently convene their boards of directors to review and monitor...more

Hogan Lovells

Spain’s AEMPS clarifies position on hydroxychloroquine, echoing statements of EMA and Lancet

Hogan Lovells on

The Spanish Agency for Medicinal Products and Medical Devices (AEMPS) stated that it will not take, for the time being, any regulatory action to temporarily suspend or halt the recruitment of patients for clinical trials to...more

Bricker Graydon LLP

COVID-19 Update: Providers participating in COVID-19 clinical trials now eligible for MIPS credit

Bricker Graydon LLP on

On April 20, 2020, the Centers for Medicare & Medicaid Services (CMS) announced that clinicians participating in clinical trials and reporting clinical information related to COVID-19 may now earn credit in the Merit-Based...more

McDermott Will & Emery

[Webinar] Critical Business Considerations for Life Sciences and Medical Device Companies Amid the COVID-19 Pandemic - April 17th,...

McDermott Will & Emery on

Life sciences and medical device companies are dealing with an unprecedented crisis. The industry is not only managing the impact of Coronavirus (COVID-19), they are also a solution provider. Companies are rapidly adapting...more

Hogan Lovells

The impact of COVID-19 on clinical trials and countermeasure development in Japan

Hogan Lovells on

On 19 March 2020, the Ministry of Health, Labour and Welfare of Japan (MHLW) issued a notice announcing a waiver of the statutorily-required waiting period after submitting a request for clinical trial to the MHLW in respect...more

Hogan Lovells

Cooperation in the life sciences industry and EU competition law in the context of COVID-19

Hogan Lovells on

The life sciences industry is facing unprecedented demands due to COVID-19. From front line carers to researchers and scientists, significant efforts are being put towards caring for those suffering from COVID-19 and...more

Hogan Lovells

Japan waives clinical trial waiting period for COVID-19 treatments

Hogan Lovells on

On 19 March 2020, the Ministry of Health, Labour and Welfare of Japan (MHLW) issued a notice announcing a waiver of the statutorily-required waiting period after submitting a request for clinical trial to the MHLW in respect...more

Epstein Becker & Green

FDA Issues Guidance for Ongoing Clinical Trials During COVID-19 Pandemic

Epstein Becker & Green on

On Wednesday, March 18, 2020, the Food and Drug Administration (“FDA”) issued a guidance document titled, “FDA Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic” (the “Guidance”)....more

Hogan Lovells

The global impact of COVID-19 on clinical trials and countermeasure development

Hogan Lovells on

The World Health Organization (WHO) has determined that the 2019 novel coronavirus is a “global pandemic” and President Trump has declared a national emergency as the impact of the virus on all aspects of daily life continues...more

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