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Research and Development › New Guidance › Life Sciences

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

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

Akin Gump Strauss Hauer & Feld LLP

Life Sciences Regulators Must Write Cloud-Specific Guidance

Akin Gump Strauss Hauer & Feld LLP on

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

Health Care Compliance Association (HCCA)

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

Health Care Compliance Association (HCCA) on

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

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

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

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