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Research and Development Department of Justice (DOJ)

Stevens & Lee

DOJ and FTC Withdraw Guidelines for Collaborations Among Competitors

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The Justice Department’s Antitrust Division and the Federal Trade Commission (Agencies) announced on Dec. 11, 2024, that they have withdrawn the Antitrust Guidelines for Collaborations Among Competitors (Guidelines) issued in...more

Health Care Compliance Association (HCCA)

Penn State, GA Tech Cybersecurity Cases Join 10 Others FCA Attorney Has Under Seal

Note to research compliance officials still digesting news of Pennsylvania State’s recent $1.25 million settlement over False Claims Act (FCA) allegations related to cybersecurity and the government’s recent intervention in a...more

Miller Canfield

Getting an Erroneous Tax Refund Case to a Jury is a Fraught Task in the Fifth Circuit

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In Grigsby v. United States, the Justice Department used discovery procedures in federal district court essentially to audit a taxpayer’s federal income tax credits for research activities. The court found that the taxpayer...more

Health Care Compliance Association (HCCA)

NIH Disavows China Initiative, Offers ‘Trusted Asians’ Support But Cases, Questions Linger

In recent months, NIH signaled that it, in the words of Director Monica Bertagnolli, understands the “difficult climate for our valued Asian American, Asian immigrant and Asian research colleagues who may feel targeted and...more

Health Care Compliance Association (HCCA)

[Virtual Event] Research Compliance Conference - November 12th, 8:00 am - 5:00 pm CT

Stay on top of developments in healthcare research compliance - Whether you missed the 2024 in-person Higher Education & Healthcare Research Compliance Conference in New Orleans, or are looking for additional insights...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: August 2024

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

Husch Blackwell LLP

False Claims Act Insights - Eureka! Government Investigators Seek Out Research Misconduct

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Host Jonathan Porter welcomes Husch Blackwell attorney Karen Courtheoux to the show to discuss the False Claims Act in the context of government-funded research programs that are often carried out under the auspices of...more

Mintz - Antitrust Viewpoints

AI Provisions in Biden’s FY 2025 Budget Proposal — AI: The Washington Report

President Joe Biden’s fiscal year (FY) 2025 budget proposal includes hundreds of millions of dollars allocated towards executive branch AI efforts. The budget proposal’s AI-related provisions can be sorted into three...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

Foley Hoag LLP - White Collar Law &...

Reflecting on Higher Education Compliance and Investigations Trends in 2023 and Looking Ahead to 2024

This is the fifth in our 2024 Year in Preview series examining important trends in white collar law and investigations in the coming year. We will be posting further installments in the series throughout the next several...more

Health Care Compliance Association (HCCA)

Moffitt Center’s FCA Settlement is First of 2024; Questions Surround Nature of Billing Errors

Moffitt Cancer Center’s recent $19.5 million settlement with the U.S. Department of Justice (DOJ) and the state of Florida resolving allegations that billing errors violated the False Claims Act (FCA) triggered a “fully...more

Akin Gump Strauss Hauer & Feld LLP

NIST Zeroes In on AI: New Government Actions to Keep Up with Rapid Tech Advance

In response to the exponential growth of artificial intelligence (AI) technologies over the past few years, the United States (U.S.) Department of Commerce’s National Institute of Standards and Technology (NIST) has been...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Regulating AI: An Overview of Federal Efforts

This first part of a two-part series on U.S. regulation of artificial intelligence systems provides an overview and modern context for the existing regulatory, legal and risk management landscape for AI systems in the U.S.,...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 20, Number 2. Citing ‘Deception,’ Not ‘Espionage,’ Judge in KU Case Imposes Supervised...

Report on Research Compliance Volume 20, Number 2. (January 2023) -Since his arrest in August 2019, Feng “Franklin” Tao has published 16 “research articles” for the University of Kansas (KU), authored a book and began...more

Health Care Compliance Association (HCCA)

[Virtual Event] 2022 Research Conference - October 6th, 8:25 am - 4:30 pm CDT

Stay on top of the latest in research compliance - Do you want to learn: - Current best practices for building and maintaining a  research compliance work plan? - How to better shift your program’s research focus in...more

Hogan Lovells

FTC workshop highlights potential changes to agency’s review of pharmaceutical mergers

Hogan Lovells on

On June 14 and 15, 2022 the Federal Trade Commission (FTC) hosted a workshop titled “Future of Pharmaceuticals: Examining the Analysis of Pharmaceutical Mergers.” The workshop was a culmination of the work of the...more

Vicente LLP

NIDA Monopoly is Over: New DEA-Registered Cannabis Growers Can Supply Researchers with Product

Vicente LLP on

It seems like every day I read a new story about legislators, high-ranking federal officials, and frustrated advocates of marijuana research complaining that researchers still can't study the actual marijuana that people are...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

Robins Kaplan LLP

[Remote Event] Health Care Antitrust Under President Biden - What Health Care Companies May Expect By Way Of Antitrust Policy And...

Robins Kaplan LLP on

After a turbulent year that roiled the economy, and the health care sector more than most, the Democrats emerged with control of both the White House and Congress for the first time since 2014. Business leaders and in-house...more

Health Care Compliance Association (HCCA)

MITRE: Risk Approach May Thwart Foreign Threats, Better Federal Info, Support Essential

Report on Research Compliance 18, no. 2 (February 2021) - “I don’t want to be on the front page of the paper with my best researcher being dragged off in handcuffs. It doesn’t look good for our university,” a senior...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

Pillsbury Winthrop Shaw Pittman LLP

Trump vs. Biden: Technology and the Internet

In this election cycle, technology and internet policy is a persistent factor across multiple issue areas. With implications for national security, economic equality, infrastructure and market regulation, the next...more

Akerman LLP - Health Law Rx

DOJ Antitrust Division Grants Green Light for Pharma Companies Sharing COVID-19 Treatment Drug Production Information

The Department of Justice Antitrust Division has advised several pharmaceutical companies that they can share competitive information regarding the status of their respective efforts to develop a COVID-19 treatment without...more

Baker Donelson

Thousand Talents Program Exposes New Legal Risks for Universities

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University professors' involvement in the Peoples' Republic of China's Thousand Talents Plan (the Talents Plan) has been in the news quite a bit recently. In recent months, the Department of Justice (DOJ) has made multiple...more

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