News & Analysis as of

Life Sciences Research and Development Scientific Research

Health Care Compliance Association (HCCA)

In This Month’s E-News: May 2024

Some funding applications submitted to NIH beginning Jan. 25 will face new requirements and undergo a revised peer review process. To prepare investigators and institutions, NIH launched a dedicated website with details about...more

Health Care Compliance Association (HCCA)

‘If Only She Could Have Been Stronger’: Miami Trial Fraud Leads to Prison, Personal Loss

In September 2015, while working in an office on the grounds of Mercy Hospital in Miami, Ivette Maria Portela Martinez learned about an upcoming clinical trial for treatment of symptoms of Clostridium difficile infections and...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: April 2024

Arguing that the National Science Foundation (NSF) was “intricately involved” when it made a $1.125 million fixed amount subaward, Oklahoma University (OU) objected to a recent finding by auditors for the NSF Office of...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: December 2023

Report on Research Compliance 20, no. 12  (December 2023) Although the National Science Foundation (NSF) allowed more than half the costs questioned by auditors for its Office of Inspector General (OIG), the California...more

Hogan Lovells

FDA authority to conduct bioresearch monitoring inspections expanded by appropriations legislation

Hogan Lovells on

U.S. President Biden recently enacted the “Consolidated Appropriations Act, 2023,” a $1.7 trillion omnibus funding bill that contains the Food and Drug Omnibus Reform Act (FDORA). Below we analyze how Section 3612 of FDORA,...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 19, Number 12. In This Month’s E-News: December 2022

The Council on Governmental Relations (COGR) is sounding an alarm regarding costs institutions have expended to comply with “new and clarified provisions calling for researchers to disclose all sources of research support and...more

ArentFox Schiff

[Webinar] Explore the Multiverse with Theoretical Physicist Dr. Michio Kaku - November 10th, 12:00 pm - 1:15 pm EST

ArentFox Schiff on

The renowned theoretical physicist Dr. Michio Kaku joins Fox Forum to discuss immortality, time travel, whether we are living in a simulation, string theory, when AI and the robots will take over, and the inventions that...more

Health Care Compliance Association (HCCA)

Research Integrity ‘Whistleblower’: Don’t Ignore Outsiders, Train Senior Investigators

Report on Research Compliance 18, no. 7 (July 2021) - Elisabeth Bik will not be silenced. While Bik, who has a doctorate in microbiology, has been active in calling out fraudulent research for several years, she gained...more

Goodwin

Propsci – An Underestimated Real Estate Asset Class In Germany

Goodwin on

World affairs are currently clouded by the global COVID-19 pandemic. In a very short period of time, approximately 191 vaccine projects have been launched according to the World Health Organization (WHO). Among the countries...more

Hogan Lovells

HHS now requires public posting of a decade of clinical trial results that were previously exempted

Hogan Lovells on

Earlier this year, we wrote about a ruling by the U.S. District Court for the Southern District of New York that, if upheld, would require companies to make public a decade of clinical trial results for products that have...more

Dechert LLP

Dispute Boards: A Novel Dispute-Resolution Technique for Life Sciences Companies Fighting COVID-19

Dechert LLP on

In these unprecedented times, life sciences companies are partnering up — sometimes in a matter of days — to find potential vaccines or treatments to the COVID-19 virus. In an effort to help the world beat the pandemic that...more

Hogan Lovells

New scientific data rules in China: China claims "data sovereignty"

Hogan Lovells on

In March of this year, the State Council released the Scientific Data Administrative Measures, a set of rules with the seemingly innocuous aim of collecting and making public the results of government-funded scientific...more

Knobbe Martens

The Druggable Microbiome

Knobbe Martens on

Discoveries regarding the role of the microbiome in human health and disease have been emerging with stunning frequency. While each new discovery builds upon the last, occasionally a point is reached at which, in the...more

Troutman Pepper

NIH May Own Gilead's Blockbuster Hepatitis Drug Due to Misstep

Troutman Pepper on

Every year, the National Institutes of Health (NIH) spends billions of federal dollars on research and development of new drugs and therapies for treating and preventing serious illnesses....more

McDonnell Boehnen Hulbert & Berghoff LLP

Guest Post -- The Emergent Microbiome: A Revolution for the Life Sciences – Part I, R&D Leaders

This is the first installment in a series on advancements in microbiome research and development. Our goal with this series is to inform readers about developments in this important and growing field and to highlight, where...more

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