News & Analysis as of

Research and Development Public Comment

Jenner & Block

Client Alert: White House Advances Development of New Artificial Intelligence Action Plan and R&D Strategy

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Recent activity by the White House Office of Science and Technology Policy (OSTP) highlights the Federal government’s ongoing focus on US leadership in artificial intelligence (AI) and opportunities for public input. On April...more

Miller Canfield

Comments Solicited on Michigan Research Credit Draft Notice

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The Michigan Department of Treasury released a draft of a notice regarding the new research and development credit. ...more

MoFo Life Sciences

USPTO Seeks Input On Experimental Use Exception To Patent Infringement And Possible Legislative Action

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On June 28, 2024, the United States Patent and Trademark Office (USPTO) issued a Notice requesting public comments on the current state of the common law experimental use exception to patent infringement and whether Congress...more

Nelson Mullins Riley & Scarborough LLP

New FDA Draft Guidance Updates Recommendations for Good Clinical Practices

The U.S. Food and Drug Administration (FDA) recently published a draft of its updated Good Clinical Practice (GCP) guidance for modernizing clinical trials. The draft guidance will be open for public comment for 60 days from...more

Skadden, Arps, Slate, Meagher & Flom LLP

Proposed EU Competitor Cooperation Guidelines Tougher on Information Sharing, but Scope Provided for Sustainability Agreements

The European Commission (Commission) is accepting public comment on its proposed revisions to European Union regulations and guidance on common competitor cooperation arrangements, which are due to expire on 31 December 2022....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

White & Case LLP

JFTC and METI Proposed Guidelines for Business Collaboration with Startups

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On December 23, 2020, the Japan Fair Trade Commission ("JFTC") and Ministry of Economy, Trade and Industry ("METI") proposed a draft of Guidelines for Business Collaboration with Startups ("Guidelines") for the purpose of...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

Goodwin

Commerce Department Proposes New Export Controls On Gene-Editing Software That Will Also Expand The Scope Of Mandatory CFIUS...

Goodwin on

On Friday, November 6, 2020, the Commerce Department’s Bureau of Industry & Security (BIS) issued a Notice of Proposed Rulemaking (NPRM) seeking public comment regarding newly-proposed controls on certain software for...more

Jones Day

Artificial Intelligence and the Biopharmaceutical Industry: What's Next?

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The Situation: Artificial intelligence ("AI") is emerging as a key driver of innovation in the biopharmaceutical industry, which uses AI in research and development ("R&D") to analyze big data. The Result: AI is already...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

Dechert LLP

New Government Regulation of Emerging Technology

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The U.S. Government has instituted a major new initiative to regulate emerging technology, potentially including artificial intelligence, biotechnology, robotics, data analytics and many other types of emerging technology,...more

Foley & Lardner LLP

Update: Antitrust-Intellectual Property Licensing Guidelines

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The Antitrust Division of the Department of Justice (DOJ) and the Federal Trade Commission (FTC) announced, on August 12, 2016, they are seeking public comments on the first update to the Antitrust Guidelines for the...more

Bergeson & Campbell, P.C.

Draft 2016 NNI Strategic Plan Available for Public Comment

On September 13, 2016, the National Nanotechnology Initiative (NNI) announced in the Federal Register the availability of the draft 2016 NNI Strategic Plan for public comment. The NNI Strategic Plan represents a consensus...more

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