News & Analysis as of

Regulatory Requirements Research and Development

Carlton Fields

“Restoring Gold Standard Science” Executive Order Steps Away From Biden Administration’s “Equitable” Approach

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Both President Trump’s and President Biden’s administrations have emphasized in executive orders and presidential memoranda the need for objective, science-based decision-making. However, Trump’s May 23, 2025, Executive Order...more

Lathrop GPM

Trump Executive Order Restricts Funding for “Dangerous Gain-of-Function Research”

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On May 5, the Trump administration issued Executive Order 14292, “Improving the Safety and Security of Biological Research,” which effectively ends federal funding for “dangerous gain-of-function research” and other life...more

Sheppard Mullin Richter & Hampton LLP

Guarding Against the Unknown: M&A Due Diligence of AI Companies in Data-Sensitive Sectors

M&A in the AI sector is redefining deal risk, especially when sensitive data is involved. As AI companies power breakthroughs in biotech, healthcare, defense, and critical infrastructure, the stakes for companies acquiring...more

Troutman Pepper Locke

Embattled Biotechs Facing Uncertainty at the FDA Look to Collaborative Deal Structures

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Biotechs have faced several challenging years with slumping valuations and a competitive funding environment. However, the latest slew of retirements and layoffs at the FDA could present their greatest challenge yet....more

Latham & Watkins LLP

FDA and NIH Announce Initiatives to Reduce Animal Testing and Encourage Alternative Methodologies

Latham & Watkins LLP on

The initiatives reflect the latest measures from federal agencies to reduce and ultimately replace animal testing in drug development and biomedical research....more

Sheppard Mullin Richter & Hampton LLP

Reflections on the FDLI 2025 Annual Conference – Differing Tones, Shared Goals

From “gold standard science” to biopharma “GNC store”, this year’s Food and Drug Law Institute (FDLI) 2025 Annual Conference in Washington, DC, on May 15–16, a vital gathering for life sciences professionals, was full of...more

Knobbe Martens

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

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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

Gardner Law

Why Compliance Audits Are Non-Negotiable

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In today’s heightened enforcement environment, compliance auditing isn’t just a best practice—it’s a necessity. Federal and state laws and industry guidance, including the Office of Inspector General (OIG) Compliance Program...more

Mintz

Trump Administration Receives 8,755 Comments for AI Action Plan — AI: The Washington Report

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The Trump administration’s Office of Science and Technology Policy received 8,755 comments in response to its Request for Information for the development of its AI Action Plan implementing the Trump AI Executive Order issued...more

Husch Blackwell LLP

Navigating Clinical Research Agreements and Regulatory Strategy for Successful Commercialization

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Clinical research agreements (CRAs) and developing a regulatory strategy—particularly in connection with the Food and Drug Administration (FDA)—are crucial for a company’s ability to bring innovative life sciences products to...more

Cozen O'Connor

Democratic AGs Block NIH Grant Cuts

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A coalition of 22 Democratic AGs obtained a preliminary injunction blocking the implementation of the Supplemental Guidance to the 2024 NIH Grants Policy Statement: Indirect Cost Rates (Rate Change Notice), which would have...more

Venable LLP

Another Change, Did You See NIH's Near-Immediate Change to Your Indirect Cost Rate?

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Over the past few weeks, the Trump administration has introduced sweeping changes across the federal government that have impacted the federal grantee and contractor community. Adding to these changes, the National Institutes...more

Orrick, Herrington & Sutcliffe LLP

Startup e Innovazione: le novità per il 2025

La legge 16 dicembre 2024, n.193 introduce significative modifiche normative che riguardano le startup innovative, gli incubatori certificati e gli investimenti nel settore delle nuove imprese tecnologiche. Queste...more

Health Care Compliance Association (HCCA)

Tackling Review of ‘Uninformative’ Studies, SACHRP Joins Quest to Boost Research Caliber

In 2023, after two years of study, an NIH task force proposed a series of recommendations to improve stewardship of research it funds, including that the agency adopt “stopping rules” that would allow poorly designed or low...more

Foley Hoag LLP - Cannabis and the Law

U.S. Virgin Islands Opens Adult-Use Cannabis License Application Process

On April 17, 2024, the Virgin Islands Cannabis Advisory Board (“VICAB”) approved regulations outlining the requirements for its new adult-use cannabis program, including details regarding the competitive merit-based...more

Troutman Pepper Locke

Navigating the Uncertain Waters of Marijuana Research in the US

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In recent years, federal and state governments have taken action to make marijuana research easier. These actions are a step in the right direction, and researchers operating in the marijuana space must be aware of the...more

Health Care Compliance Association (HCCA)

New ORI Misconduct Rule Offers ‘Thoughtful’ Revisions in Wake of Highly Criticized NPRM

Now that the HHS Office for Research Integrity (ORI) has published its final rule revising 2005 regulations governing misconduct, compliance officials could be engaging in three activities simultaneously: checking to see if...more

McDermott Will & Emery

Pharma and MedTech Services Investment Summit 2024

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The inaugural Pharma and MedTech Services Investment Summit brought together C-suite executives, senior private equity professionals, investment bankers and other industry leaders for a deep dive into the investment...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

McDermott Will & Emery

[Event] Pharma and MedTech Services Investment Summit 2024 - May 2nd, San Francisco, CA

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YOUR SOURCE FOR SUCCESS IN PHARMA AND DEVICE SERVICES INVESTING - Join C-suite executives, senior private equity professionals, investment bankers and other industry leaders for a deep dive into the investment...more

Health Care Compliance Association (HCCA)

Understanding the requirements for waiving or altering HIPAA authorization for research

The HIPAA Privacy Rule sets forth provisions related to the waiver or alteration of authorization in relation to clinical research studies for circumstances in which it would be impractical or impossible to obtain...more

Goodwin

Master(ing) Protocols for Randomized Umbrella and Platform Trials

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The U.S. Food and Drug Administration (FDA) recently issued a draft guidance, “Master Protocols for Drug and Biological Product Development”, that echoes and builds on principles that the Agency previously set forth in...more

Health Care Compliance Association (HCCA)

As AI-Assisted Research Advances, Experts Share Worries, Oversight Strategies; Collaboration Urged

At Cornell University, institutional review board (IRB) members meet with the chief information security officer and a liaison to the general counsel’s office. Their regular attendance has been “really critical,” said IRB...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: November 2023

Report on Research Compliance 20, no. 11 (November, 2023) City University of New York (CUNY ) has accused neuroscientist Hoau-Yan Wang, a CUNY faculty member and longtime collaborator with embattled biotech firm Cassava...more

Health Care Compliance Association (HCCA)

[Virtual Event] Research Compliance Conference - November 9th, 8:00 am - 5:00 pm CT

Get the latest strategies and insights for healthcare research compliance - Whether you missed this year’s in-person Research Compliance Conference or are looking for additional insights from research colleagues and...more

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