News & Analysis as of

Regulatory Oversight Scientific Research

Bergeson & Campbell, P.C.

President Signs EO to Restore Gold Standard for Science, Calls for Reevaluation of Biden Administration’s Scientific Integrity...

On May 27, 2025, President Trump signed an Executive Order (EO) on “Restoring Gold Standard Science.” 90 Fed. Reg. 22601. The EO states that the Trump Administration “is committed to restoring a gold standard for science to...more

Health Care Compliance Association (HCCA)

Delayed Action on Misconduct Costs Firm $4M; FCA Whistleblower Flagged Earlier Application

Scientist and pharmaceutical researcher Andrew P. Mallon—who first reported to NIH and others in 2016 his suspicions that then-Athira Pharma CEO Leen Kawas falsified data in published papers—filed the whistleblower suit...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

Sheppard Mullin Richter & Hampton LLP

Bridging the Gap: Cannabis Rescheduling to Align Policy with Research

In a much-anticipated move, sources recently reported that the Drug Enforcement Administration (“DEA”) will recommend rescheduling cannabis from a Schedule I substance to a Schedule III substance under the federal Controlled...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

Holland & Knight LLP

New Artificial Intelligence Executive Order Contains Numerous Healthcare Implications

Holland & Knight LLP on

President Joe Biden on Oct. 30, 2023, signed a sweeping executive order (EO) and invoked the Defense Production Act to establish the first set of standards for using artificial intelligence (AI) in healthcare and other...more

Shook, Hardy & Bacon L.L.P.

Study Reportedly Finds Potential Links Between Erythritol and Cardiovascular Risk

A study published February 27, 2023, in the journal Nature Medicine has purportedly found possible links between erythritol and major adverse cardiovascular events such as heart attack or stroke. Erythritol is an artificial...more

McDermott Will & Emery

[Webinar] 2021 +Dx Diagnostics Forum - April 6th, 12:00 pm - 3:30 pm EST

McDermott Will & Emery on

Celebrating its sixth program, McDermott+Consulting’s +Dx Diagnostics Forum is the premier annual program for the laboratory diagnostics community. Gain insight into how the industry addresses regulatory and business...more

Health Care Compliance Association (HCCA)

Leadership Jobs Finally Filled, ORI Seeks Input on Sequestering Digital Evidence

Report on Research Compliance 17, no. 6 (June 2020) - With the recent appointment of an HHS leader as its permanent director and a former Johns Hopkins misconduct official to another key post, the HHS Office of Research...more

Hogan Lovells

New scientific data rules in China: China claims "data sovereignty"

Hogan Lovells on

In March of this year, the State Council released the Scientific Data Administrative Measures, a set of rules with the seemingly innocuous aim of collecting and making public the results of government-funded scientific...more

Polsinelli

Animal Testing to Decrease with New EPA Rules

Polsinelli on

The United States Environmental Protection Agency made two moves recently to reduce the use of animals in chemical testing and pesticide registration: One under FIFRA and one under TSCA. ...more

Bricker Graydon LLP

What’s new with the Common Rule? Clinical research and Common Rule updates

Bricker Graydon LLP on

The updates to the Common Rule, effective January 19, 2018, make some significant changes of which those involved in government-funded clinical research involving human subjects should be aware. These changes include...more

Hogan Lovells

Italy approves new provisions on informed consent and advance decision of medical treatments – Why it matters for clinical trials...

Hogan Lovells on

On December 14th, 2017, the Italian Senate passed a long-awaited bill (DDL no 2801) governing the informed consent to medical treatments, which also allows individuals to express their wishes on medical treatments in the...more

Akerman LLP - Health Law Rx

Get your Single IRB lined up for Multi-Site Research

Changes to the federal regulations governing the protection of human subjects participating in research (known as the Common Rule) were amended earlier this year. The changes to the Common Rule impact research conducted,...more

Hogan Lovells

French Legal and Regulatory Update – December 2016

Hogan Lovells on

The Paris office of Hogan Lovells is pleased to provide this English language edition of our monthly e-newsletter, which offers a legal and regulatory update covering France and Europe for December 2016. ...more

WilmerHale

Freedom to Utilize Genetic Resources? The Nagoya Protocol Two Years Later

WilmerHale on

Two years ago today, the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits from their Utilization to the Convention on Biological Diversity (“Protocol”) entered into international...more

16 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide