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Research and Development New Guidance

Jones Day

Blurring the Line Between the Dry and Wet Lab: Joint Inventorship in AI-Assisted Life Science Inventions

Jones Day on

In 2024, not one but two Nobel Prizes (in Chemistry and Physics) were awarded to researchers for their work in artificial intelligence ("AI"). Particularly noteworthy for the life science community is the Nobel Prize in...more

Knobbe Martens

FDA Publishes Case Studies and User Guide for Rare Disease Drug Developers

Knobbe Martens on

Drug development programs face unique challenges in demonstrating the safety and effectiveness of drugs for treating rare diseases. The FDA’s Accelerating Rare disease Cures (ARC) Program started the Learning and Education to...more

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

This Summer in Artificial Intelligence: Newly Released USPTO Guidance and Exemplary Worldwide Inventorship Updates

The United States Patent and Trademark Office (USPTO) recently published new guidance on subject-matter eligibility as related to Artificial Intelligence (AI), opening a written comment window to respond with a deadline of...more

Eversheds Sutherland (US) LLP

Sound familiar? IRS releases year-end procedural accounting method guidance regarding the treatment of R&D expenditures under...

Not unlike the last minute procedural guidance released at the end of last year addressing Section 174, on December 22, 2023, the Department of the Treasury (Treasury) and the Internal Revenue Service (IRS) released Notice...more

Fenwick & West LLP

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

Fenwick & West LLP on

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

Cornerstone Research

Potential Unintended Economic Impacts of the Inflation Reduction Act on the Pharmaceutical Industry

Cornerstone Research on

The Inflation Reduction Act (IRA) was signed into law in August 2022 with the goal of curbing inflation by, among other things, lowering prescription drug prices. Notable prescription drug provisions of the IRA include the...more

Akin Gump Strauss Hauer & Feld LLP

Life Sciences Regulators Must Write Cloud-Specific Guidance

Cloud services have revolutionized the way businesses and governments operate, offering scalability, flexibility, cost-efficiency and security. This is especially the case in the life sciences industry, where the cloud has...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)

‘No More Boutique Studies’: NIH Mulls ‘Stopping Rules,’ Other Changes to Improve Clinical Trials

At some point in the future, NIH may halt funding for clinical trials deemed too underpowered to produce meaningful findings or that fail to meet enrollment goals. To do this, the agency would have to adopt so-called...more

Perkins Coie

FDA Releases Guidance on Clinical Research into Cannabis-Derived Drugs

Perkins Coie on

The U.S. Food and Drug Administration (FDA) recently released new guidance on sourcing and product quality to companies conducting clinical research related to the development of human drugs involving cannabis or...more

King & Spalding

EPA Releases a Cumulative Impacts Addendum to its Environmental Justice Tool Kit

King & Spalding on

On January 11, 2023, EPA’s Office of the General Counsel released a Cumulative Impacts Addendum (“Addendum”) to its May 2022 publication Legal Tools To Advance Environmental Justice, continuing to signal its focus on...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 19, Number 10. In This Month’s E-News: October 2022

Report on Research Compliance 19, no. 10 (October, 2022) - Beginning Oct. 1, Renee Wegrzyn will be the first permanent director of the Advanced Research Projects Agency for Health (ARPA-H), the new HHS agency modeled...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

White & Case LLP

The new draft EU horizontal antitrust rules – A snapshot overview

White & Case LLP on

On 1 March 2022, the European Commission ("EC") published for consultation two draft revised horizontal block exemption regulations ("HBERs") on research & development ("R&D") and specialisation agreements, as well as draft...more

Hogan Lovells

FDA issues new policy for evaluating impact of viral mutations on COVID-19 tests

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) has issued new guidance for COVID-19 test developers to evaluate the impact of emerging and future viral mutations on COVID-19 tests. The SARS-CoV-2 virus has mutated over time,...more

White & Case LLP

Amendments to the JFTC Merger Guidelines and Policies in accordance with Digital Economy

White & Case LLP on

The Japan Fair Trade Commission ("JFTC") amended the "Guidelines to Application of the Antimonopoly Act Concerning Review of Business Combination" ("Guidelines") and the "Policies Concerning Procedures of Review of Business...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

Hogan Lovells

Four new FDA guidances and proposed rule advance biosimilars policy framework

Hogan Lovells on

Yesterday, FDA released a series of guidances that aim to advance the agency’s biosimilars policy framework, along with a proposed rule on the definition of a “biological product,” which incorporates changes made by the...more

Morgan Lewis

FDA Issues Guidance on Expanded Access

Morgan Lewis on

The Agency improves the process for access to investigational drugs and biologics for patients who lack other options. On June 2, the US Food and Drug Administration (FDA or the Agency) announced that it finalized three...more

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