News & Analysis as of

Investigations Research and Development

Health Care Compliance Association (HCCA)

And Then There Were Nine: Disappearing OHRP To Join Enforcement Agency; NIH Cuts Outlined

When it comes to changes roiling the federally supported research landscape, April offered no letup from the first three months of the year; if anything, the pace and magnitude increased. In one instance, an agency—the HHS...more

Health Care Compliance Association (HCCA)

Tackling Review of ‘Uninformative’ Studies, SACHRP Joins Quest to Boost Research Caliber

In 2023, after two years of study, an NIH task force proposed a series of recommendations to improve stewardship of research it funds, including that the agency adopt “stopping rules” that would allow poorly designed or low...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

K&L Gates LLP

Long-Awaited Changes to Research Misconduct Rules Have Arrived

K&L Gates LLP on

On 12 September 2024, the Office of Research Integrity (ORI) within the US Department of Health and Human Services (HHS) issued a final rule (Final Rule) that significantly modified the standards, procedures, and requirements...more

ArentFox Schiff

Continuing Forward: Senate Leaders Release an AI Policy Roadmap

ArentFox Schiff on

The US Senate’s Bipartisan AI Policy Roadmap is a highly anticipated document expected to shape the future of artificial intelligence (AI) in the United States over the next decade. This comprehensive guide, which complements...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

McDermott Will & Schulte

R&D Expenditures Need Only Relate to Subset of Domestic Industry Product

Addressing a decision by the US International Trade Commission finding a violation of Section 337 based on importation of certain TV products, the US Court of Appeals for the Federal Circuit agreed that the patent holder had...more

Health Care Compliance Association (HCCA)

Good investigative practices apply in all settings

As reported in the Report on Research Compliance, the Office of Inspector General (OIG) of the National Science Foundation (NSF) recently held a workshop on the performance of federal research misconduct investigations....more

Health Care Compliance Association (HCCA)

In This Month’s E-News: November 2023

Report on Research Compliance 20, no. 11 (November, 2023) City University of New York (CUNY ) has accused neuroscientist Hoau-Yan Wang, a CUNY faculty member and longtime collaborator with embattled biotech firm Cassava...more

Health Care Compliance Association (HCCA)

Where’s the Proof? NSF OIG Provides Insights on Crafting That All-Important Investigation Report

Report on Research Compliance Volume 20, no. 10 (October, 2023) Please don’t send uncorrected transcripts of interviews conducted via Zoom or other means to the National Science Foundation (NSF) Office of Inspector General...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: October 2023

Report on Research Compliance Volume 20, no. 10 (October, 2023) The HHS Secretary’s Advisory Committee on Human Research Protections (SACHRP) will have two new members when it meets this month. In an email sent to its...more

Hogan Lovells

Collaborative research is blurring boundaries between sponsored studies and IIS

Hogan Lovells on

Industry is revising its models in clinical development: new collaborative research between the industry and investigators is becoming more important, resulting in an in-between approach between industry sponsored studies and...more

Jackson Walker

Key Considerations for Clinical Investigators When Negotiating Clinical Trial Agreements

Jackson Walker on

Clinical trials are an essential component of the research architecture for developing new drugs and devices. Research institutions and their clinical investigators (“Investigators”) play an important role in supporting drug...more

Health Care Compliance Association (HCCA)

[Event] Research Compliance Conference - June 11th - 13th, Chandler, AZ

Get the latest insights in research compliance - The risks and challenges that come with clinical research are unique, as are the abundance of government regulations and enforcers that oversee them. HCCA’s Research...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 20, Number 1. In This Month’s E-News: January 2023

Alice C. Chang, formerly an associate professor of basic medical sciences in the College of Veterinary Medicine at Purdue University, “falsified and/or fabricated data from the same mouse models or cell lines by reusing the...more

Health Care Compliance Association (HCCA)

[Event] Research Compliance Conference - June 8th - 10th, Anaheim, CA

Hear about the latest in research compliance - Do you want to learn… - How to prepare for upcoming changes in Medicaid? - Ways to build and maintain a better research compliance work plan for your program? - How...more

Bass, Berry & Sims PLC

Research Using De-Identified Specimens: A Reminder from FDA

Bass, Berry & Sims PLC on

On October 18, the Food and Drug Administration (FDA) issued a letter reminding developers of in vitro diagnostics (IVDs) that institutional review board (IRB) approval is required before initiating a clinical investigation...more

Hogan Lovells

FDA updates industry on what drug & biologic inspections will occur during COVID-19 pandemic

Hogan Lovells on

On Wednesday, August 19, the U.S. Food and Drug Administration (FDA) issued guidance providing some additional insight into how the agency will determine what drug and biologic inspections may take place during the COVID-19...more

Adler Pollock & Sheehan P.C.

Driving Revenue And Deal Flow Through An Intelligent IP Strategy; Strategies For Smaller And Early-Stage Life Science Companies....

As discussed in Part I, a company’s technology must have strong intellectual property to establish a significant technology transfer program or prepare for an eventual acquisition. Establishing an intelligent IP strategy can...more

Health Care Compliance Association (HCCA)

[Virtual Event] 2020 Virtual Orange County Regional Conference - June 12th, 8:25 am - 4:30 pm PDT

Our Virtual Regional Healthcare Compliance Conferences provide updates on the latest news in regulatory requirement, compliance enforcement, and strategies to develop effective compliance programs. Watch, listen, and ask...more

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