News & Analysis as of

Research and Development Disclosure Requirements

Bass, Berry & Sims PLC

Athira Pharma Inc. Agrees to Settle False Claims Act Allegations

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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

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

ArentFox Schiff

Continuing Forward: Senate Leaders Release an AI Policy Roadmap

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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

Wiley Rein LLP

New Report from NTIA Calls for More AI Regulation

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At the end of March, the National Telecommunications and Information Administration (NTIA) issued its long-awaited AI Accountability Policy Report (Report), which provides federal policy recommendations regarding...more

Fenwick & West LLP

Fenwick Writes Comment Letter on Notice 2023-63 on Amortization of Specified Research or Experimental Expenditures under Section...

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Following the IRS’s issuance of guidance in Notice 2023-63 regarding R&D capitalization under Section 174, a working group of several Fenwick tax group attorneys commented to the IRS and the U.S. Treasury Department on...more

Morrison & Foerster LLP

A New Listing Regime for Specialist Technology Companies Has Arrived

On March 24, 2023, the Stock Exchange of Hong Kong Limited (the “Exchange”) issued the long-awaited consultation conclusions (the “Consultation Conclusions”) on the listing regime for Specialist Technology Companies on the...more

Foley Hoag LLP

Former University of Kansas Professor Sentenced for Making False Statements on Conflict of Interest Disclosure Form

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Last month, former University of Kansas Professor Feng “Franklin” Tao was sentenced to time served and two years of supervised release for making false statements in the University of Kansas’s conflict of interest and...more

Morrison & Foerster LLP

18C Is Coming to Town – Synopsis and Selected Q&A

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The Stock Exchange of Hong Kong Limited (“Exchange”) has recently published a Consultation Paper on the proposed new listing regime for Specialist Technology Companies on the Main Board by introducing a new Chapter 18C. The...more

Hogan Lovells

HK new listing regime for pre-revenue or pre-profit innovative science and technology companies

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Hong Kong Stock Exchange published a consultation paper proposing new listing regime for “Specialist Technology Companies” under a new chapter (Chapter 18C) of the Listing Rules, providing an alternative route for listing for...more

Health Care Compliance Association (HCCA)

NSF, OSTP Begin Implementing ‘CHIPS’ Act; Institutions Face New Security Requirements

Report on Research Compliance 19, no. 10 (October, 2022) - What is a malign foreign government talent recruitment program and why does it matter? This is a term with which research compliance officials managing federal...more

Perkins Coie

Forthcoming Disclosure and Security Requirements for Institutions Hosting Federally Funded Research

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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

Akin Gump Strauss Hauer & Feld LLP

Implementation Guidance for National Security Presidential Memorandum 33

Over the past three plus years, the issue of foreign influence over U.S. government-sponsored research has been front and center for the research community. There have been numerous high-profile prosecutions of professors,...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

Jones Day

White House Guidance on Implementing NSPM-33: Standardization of Disclosure and Security Measures for Federal Research Funding

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On January 4, 2022, the White House Office of Science and Technology ("OSTP") released guidance for federal agencies to implement National Security Presidential Memorandum 33 ("NSPM-33"). Issued in the final days of the Trump...more

Health Care Compliance Association (HCCA)

Universities Brace for Guidance on Security Memorandum; Agencies Plan Implementation

Report on Research Compliance 18, no. 11 (November, 2021) - If a timeline announced by the White House is met, universities and others should receive guidance later this month on securing the research enterprise as the...more

Ballard Spahr LLP

COVID-19 Disclosures Bring Risks For Life Sciences Cos.

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COVID-19 has upended every corner of the financial markets, including the disclosure regime for publicly traded companies. Over the last few weeks, the number of disclosures relating to COVID-19 has exploded, with as many...more

Perkins Coie

US Department of Education Scrutinizes Foreign Investment Into Higher Education

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The U.S. Department of Education (DOE) recently launched investigations into at least a half dozen top research institutions for failing to disclose foreign-sourced gifts or contracts. Under section 117 of the Higher...more

Skadden, Arps, Slate, Meagher & Flom LLP

California Consumer Privacy Act: A Compliance Guide

California recently enacted the Consumer Privacy Act, the most stringent privacy law in the United States. Although it does not go into effect until January 1, 2020, most companies will need a number of months to prepare. The...more

Sheppard Mullin Richter & Hampton LLP

Reading Between the Blurred Lines

The Federal Trade Commission recently released a Staff Report regarding consumer recognition of native and search advertising entitled “Blurred Lines”, summarizing its findings from its self-styled “exploratory research”....more

Jones Day

Pre-Revenue Biotech Companies Cleared to List on Hong Kong Stock Exchange

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The Situation: The Hong Kong Stock Exchange’s failure to recognize that investors are able to evaluate biotech companies in the pre-revenue stages, and its consequent refusal to list those companies for trading, is viewed by...more

Downs Rachlin Martin PLLC

News from the Vermont State House - An analysis from DRM's Government & Public Affairs Team - February 2017 #3

Act 188 Plans On Hold as New Chemical Bill is Introduced - Nearly three years after the legislature passed a law to regulate children’s products containing chemicals of high concern, a web site intended to inform the...more

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