News & Analysis as of

Public Health Clinical Trials Coronavirus/COVID-19

Holland & Knight LLP

Two Days, Two Hearings: NIH and FDA Nominees Go Before the HELP Committee

Holland & Knight LLP on

Dr. Jayanta (Jay) Bhattacharya, nominated to be Director of the National Institutes of Health (NIH), and Dr. Martin Makary, nominated to be the Commissioner of the U.S. Food and Drug Administration (FDA), appeared before the...more

McDermott Will & Schulte

Special Report - 2022 FDA Year in Review

As the United States’ primary public health and consumer protection agency, the US Food and Drug Administration (FDA) regulates at least one quarter of the nation’s economy and exerts significant influence over global...more

MoFo Life Sciences

FDA Releases Draft Guidance On Digital Health Technologies For Remote Data Acquisition In Clinical Investigations

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In response to COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) continues to work in support of clinical investigation sponsors and an evolving environment in which they run their clinical trials while...more

Faegre Drinker Biddle & Reath LLP

Long-Awaited 21st Century Cures Act 2.0 Draft Released

Following months of anticipation by stakeholders including patient organizations, research institutions and medical product developers, Representatives Fred Upton (R-MI) and Diana DeGette (D-DO) released a 21st Century Cures...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

Haug Partners LLP

When the “States” Come Marching-In: The Bayh-Dole Act’s Effect on IP Rights of COVID-Related Patents and Knowledge Ecology...

Haug Partners LLP on

On August 4, 2020, a bipartisan coalition of over 30 attorneys general led by California Attorney General Xavier Becerra and Louisiana Attorney General Jeff Landry sent a letter request to United States Health and Human...more

Patrick Malone & Associates P.C. | DC Injury...

Better Healthcare Newsletter from Patrick Malone - September 2020

Will it be a shot in the arm — or the foot? Americans have invested high hopes in a Covid-19 vaccine. Its development is racing ahead, with researchers deploying novel approaches and governments spending billions of dollars...more

Alston & Bird

Alston & Bird Health Care Week in Review - August 2020 #4

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more

Foley & Lardner LLP

Improving 21st Century Cures Act: Personalized Medicine and COVID-19

Foley & Lardner LLP on

On April 27, 2020, Representatives Fred Upton (R-Michigan) and Diana DeGette (D-Colorado) released a “concept paper” to build on the success of the 21st Century Cures Act (Pub. L. 114-255) and improve the country’s...more

Patrick Malone & Associates P.C. | DC Injury...

Better Healthcare Newsletter from Patrick Malone - May 2020

The United States built a rigorous system over decades to protect patients from harm while receiving new types of medical treatment. New drugs and new vaccines, in particular, have been barred from widespread use until they...more

International Lawyers Network

Compulsory Licensing in Russia in the view of COVID-19

Nowadays the sphere of healthcare is becoming one of the mostly discussed because of a mass spread of the coronavirus pandemic (also COVID-19). Confirmed cases of COVID-19 around the world have passed more than a 2.4 million....more

Bass, Berry & Sims PLC

FDA Issues Updated Guidance on Clinical Trial Conduct during the COVID-19 Pandemic

Earlier this month the FDA issued guidance listing general factors for study sponsors to take into consideration to assure the safety of clinical trial participants, maintain a good clinical practice, and minimize risks to...more

Hogan Lovells

COVID-19’s impact on clinical trials prompts FDA to issue guidance to assist with study conduct

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On Wednesday, March 18, the U.S. Food and Drug Administration published the guidance “Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic."...more

Shook, Hardy & Bacon L.L.P.

COVID-19 Client Primer

Cybersecurity and Health Information Privacy During the COVID-19 Pandemic - In following CDC guidelines to effectively navigate the spread of COVID-19, many employers are closing their doors for a period of time and...more

Hogan Lovells

Belgian AFMPS latest guidance in the context of COVID-19 outbreak

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The Belgian Federal Agency for Medicines and Health Products (AFMPS) released a series of guidance and recommendations over the last few days in relation to the COVID-19 outbreak. ...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

Hogan Lovells

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

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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

Hogan Lovells

AIFA provides guidance on critical aspects relating to the management of clinical trials in Italy during the COVID-19 emergency

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Due to the COVID-19 emergency and the consequent lockdown that is affecting non-essential services in Italy, including some health care services, on March 12, 2020 the Italian Medicines Agency ("AIFA") issued a Guidance,...more

Morgan Lewis

Potential Impact of Coronavirus (COVID-19) on the Pharmaceutical and Biotech Industries

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The pharmaceutical and biotech industries are assessing how the coronavirus (COVID-19) pandemic may impact business operations. Presently, most countries have confirmed cases of COVID-19 and thousands of people have had...more

Hogan Lovells

UK coronavirus guidance for clinical trials

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The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued guidance on the management of clinical trials in the context of coronavirus....more

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