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Regulatory Oversight Research and Development

BCLP

Beyond the £22BN Pledge: What the UK Needs to Do to Develop Its Carbon Capture, Usage and Storage Industry

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Last week, the UK Government pledged £22 billion towards the development of the carbon capture, usage and storage (CCUS) industry in the UK. This is a significant step towards achieving net-zero emissions by 2050. ...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

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

Troutman Pepper Locke

HHS Proposes Rescheduling Cannabis to Schedule III – What It Means for the Industry

Troutman Pepper Locke on

It has been widely reported and confirmed publicly that, on August 29, the U.S. Department of Health and Human Services (HHS) sent a letter to the Drug Enforcement Administration (DEA) recommending that cannabis be moved from...more

Bradley Arant Boult Cummings LLP

Like a Steam Locomotive, Rolling Down the Track: Biden Signs Marijuana Research Bill

For decades, the federal government only allowed scientists to research marijuana grown on the campus of the University of Mississippi. While Mississippi-grown cannabis will continue to be the subject of federally sanctioned...more

Hogan Lovells

Spain’s AEMPS clarifies position on hydroxychloroquine, echoing statements of EMA and Lancet

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The Spanish Agency for Medicinal Products and Medical Devices (AEMPS) stated that it will not take, for the time being, any regulatory action to temporarily suspend or halt the recruitment of patients for clinical trials to...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

Akin Gump Strauss Hauer & Feld LLP

Drones and Urban Air Mobility in the President’s Budget

President Trump recently released his federal budget proposal for Fiscal Year (FY) 2020. The President’s budget is always a helpful tool to identify what the administration’s policy priorities are and what we might expect to...more

Patrick Malone & Associates P.C. | DC Injury...

$1 billion+ may seem like a lot of money. It still can’t resolve many questions.

Although lawsuits can result in needed financial support and welcome recognition of harms suffered by patients seeking medical services, the civil justice system has its limits. They showed in cases in the news in which...more

Hogan Lovells

Nuclear Legislation Caps Off Nuclear Innovation Week

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The reintroduction of Nuclear Energy Leadership Act (NELA) caps off a week of activities focused on innovation, and follows on advancement of key U.S. Nuclear Regulatory Commission (NRC) guidance on advanced reactor...more

Jones Day

White House Unveils American AI Initiative: The Future Is Now

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The Situation: Recognizing the vital role that artificial intelligence ("AI") plays in the economy and national security interests of the United States, President Trump recently issued an Executive Order unveiling the...more

Bradley Arant Boult Cummings LLP

Hemp Poised for Resurgence Following Farm Bill's Passage - The National Law Journal

Centuries after American colonists were required by law to grow hemp, and decades after it was then outlawed by Congress, one of the nation’s oldest and most versatile crops is poised for a resurgence. The 2018 Farm Bill,...more

K&L Gates LLP

OHRP Provides Draft Guidance Regarding the Common Rule’s Public Health Surveillance Exclusion

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On November 19, 2018, the U.S. Department of Health and Human Services, Office for Human Research Protections (“OHRP”) announced the availability of additional draft guidance related to a new exclusion from regulatory...more

Hogan Lovells

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

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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

Hogan Lovells

Institutional Review Board “Checklist” offers tool to help protect clinical trial participants

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On May 17, HHS’s Office for Human Research Protections (OHRP) and FDA issued a joint, final guidance on written procedures for institutional review boards (IRBs). ...more

Hogan Lovells

FDA and OHRP Finalize Joint Guidance on IRB Meeting Minutes

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Ongoing Effort to Harmonize Human Subject Research Regulations The U.S. Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP), both part of the Department of Health and Human Services (HHS),...more

Ballard Spahr LLP

Obama Signs 21st Century Cures Act, Adding $6.3 Billion For Medical Research

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The Cures Act aims to increase the speed by which new drugs are brought to market by streamlining clinical trials, allowing the use of patient data in the regulatory review process, and modernizing U.S. Food and Drug...more

Foley & Lardner LLP

Self-Driving Cars: Legal Issues Ahead

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Companies including Apple, Google, Tesla, Toyota and Uber are all developing and testing self-driving car technology. Toyota announced in November that it would spend $1 billion over the next five years on research centers...more

Sheppard Mullin Richter & Hampton LLP

DoD Issues White Paper Aimed at IR&D Costs

On August 26, 2015, the Department of Defense (“DOD”) issued a White Paper announcing that, beginning in FY 2017, all defense contractors will be required to notify DOD before undertaking any new Independent Research and...more

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