News & Analysis as of

Research and Development Reporting Requirements

Bass, Berry & Sims PLC

Athira Pharma Inc. Agrees to Settle False Claims Act Allegations

Bass, Berry & Sims PLC on

On January 6, the Department of Justice (DOJ) announced that Athira Pharma Inc., a Washington-based biopharmaceutical company, agreed to pay over $4 million to settle allegations it violated the False Claims Act (FCA). The...more

Akin Gump Strauss Hauer & Feld LLP

Calling-in from COP29: What You Missed and What Comes Next

World leaders, scientists, government decision-makers, private sector actors, climate actionists and other stakeholders have convened at 29th Conference of the Parties (COP29) to the United Nations Framework Convention on...more

Wiley Rein LLP

New DOD Rules on Contractor Reporting and Mitigating Foreign Ownership, Control or Influence for Unclassified Contracts

Wiley Rein LLP on

As a result of a broader U.S. government effort to address supply chain vulnerabilities, Congress passed a new law focused on U.S. Department of Defense (DOD) contracting with certain entities that operate under foreign...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: September 2024

Report on Research Compliance 21, no. 9 (September, 2024) - Based on their review of public data on ClinicalTrials.gov, a bipartisan quartet of U.S. representatives has asked the Food and Drug Administration (FDA) to...more

Foley & Lardner LLP

Equal Employment Opportunity Commission Goes After Employers Who Failed to File EEO-1 Reports

Foley & Lardner LLP on

The EEO-1 report, mandated by Title VII of the Civil Rights Act of 1964, requires private employers with 100 or more employees, as well as employers who contract with the federal government with 50 or more employees and...more

Health Care Compliance Association (HCCA)

NY Medical College Clashes With OIG After Audit Questions $7.5M, PI Salaries, ‘Illegible Signatures’

New York Medical College (NYMC) officials thought the HHS Office of Inspector General’s (OIG) audit was wrapping up in December 2021, based on what “the original senior auditor” told them. But the auditor retired and work...more

Quarles & Brady LLP

Recent Updates to Bayh-Dole Obligations May Require New License Terms and Reporting Procedures for Federally-Funded Inventions

Quarles & Brady LLP on

Effective October 1, 2023, certain aspects of reporting obligations under the Bayh-Dole Act changed, and further changes are potentially on the way. Frequent recipients of federal funding, such as universities and research...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

Maynard Nexsen

Approaching Deadline for the 2022 Benchmark Survey of Foreign Direct Investment in the US: What You Need to Know

Maynard Nexsen on

Foreign direct investment (FDI) plays a crucial role in the global economy, and the United States has long been an attractive destination for international investors. To accurately gauge the impact and trends of FDI, the US...more

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

Keeping Your Federally-Funded Inventions: Requirements to Comply with the Bayh-Dole Act

Federal funding is a huge boon for companies, universities, and research institutions conducting innovative research. However, it comes attached with requirements that can become a stumbling block, especially for emerging and...more

Perkins Coie

Forthcoming Disclosure and Security Requirements for Institutions Hosting Federally Funded Research

Perkins Coie on

NSPM-33 National Security Presidential Memorandum-33 (NSPM-33) and implementation guidance from the National Science and Technology Council (NSTC) direct federal agencies to standardize and enhance disclosure and security...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 16, Number 12. In This Month's E-News: December 2019

Report on Research Compliance 16, no. 12 (December 2019) - NIH is seeking comment on a proposed policy for data management and sharing, as well as two related guidance documents that together seek to “promote effective and...more

Troutman Pepper Locke

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

Troutman Pepper Locke 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

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