News & Analysis as of

Biden Administration National Institute of Health (NIH)

Goodwin

USPTO Emphasizes Searches of FDA Databases for Pharmaceutical Patent Applications

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In response to Biden Administration goals regarding increasing pharmaceutical competition and lowering drug prices, the USPTO recently released training provided to the USPTO examining corps on utilizing publicly available...more

Holland & Knight LLP

Holland & Knight Health Dose: February 27, 2024

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

McDermott Will & Emery

Biden Administration Proposes New Framework for Exercising March-In Rights on Government-Funded Inventions; Drug Pricing May Be...

McDermott Will & Emery on

Under the University and Small Business Patent Procedures Act of 1980 (35 U.S.C. §§ 200-212), commonly referred to as the Bayh-Dole Act, the federal government can exercise “march-in” authority in certain circumstances to...more

Sunstein LLP

When the NIH comes Marching In - Or Not

Sunstein LLP on

In an attempt to rein in rising drug prices, the Biden administration unveiled a proposed framework of factors that federal agencies should consider when choosing whether to exercise so-called “march-in rights.” March-in...more

King & Spalding

The Administration Takes Aim At Drug Prices Again – This Time Through A Controversial Framework for Exercising March-In Rights

King & Spalding on

The Biden Administration recently announced a plan to leverage an old tool in a new way to try to reduce drug costs: exercising “march-in rights” under the Bayh-Dole Act for drugs that were supported by government funding. ...more

Morrison & Foerster LLP - Government...

Biden Administration Proposes Novel Use Of Price As Justification For Agency Exercise Of March-In Rights For Government-Funded...

Presented as part of its effort to lower what it views as excessive prices for prescription drugs, the Biden administration on December 7, 2023, announced the release of a proposed framework to expand the use of government...more

Foley Hoag LLP

Biden Administration Releases Draft Framework for Exercising Bayh-Dole March-in Rights Taking Into Account Drug Prices

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On December 7, the White House announced “New Actions to Lower Health Care and Prescription Drug Costs by Promoting Competition,” which included “a proposed framework for agencies on the exercise of march-in rights on...more

Holland & Knight LLP

Holland & Knight Health Dose: November 7, 2023

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

Sheppard Mullin Richter & Hampton LLP

Hair Products with Formaldehyde Are Going Out of Style: Is Your Organization Ready for the Change?

On June 13, the Biden Administration released its Spring 2023 Unified Agenda of Regulatory and Deregulatory Actions, which announced its plan to propose a rule that would ban the inclusion of formaldehyde and other...more

Holland & Knight LLP

Holland & Knight Health Dose: October 31, 2023

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. ...more

Holland & Knight LLP

Holland & Knight Health Dose: October 17, 2023

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. ...more

Holland & Knight LLP

Holland & Knight Health Dose: October 3, 2023

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. ...more

Holland & Knight LLP

Holland & Knight Health Dose: January 24, 2023

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. This week's topics include: ...more

Perkins Coie

House Passes Bill to Expand Cannabis and CBD Research

Perkins Coie on

In late July, the U.S. House of Representatives passed H.R. 8454, the Medical Marijuana and Cannabidiol Research Expansion Act (Research Expansion Act). A similar version of the bill, S. 253, passed the Senate earlier this...more

Foley Hoag LLP

FDA Issues Draft Guidance Recommending "Race and Ethnicity Diversity" Plans for Clinical Trial Sponsors

Foley Hoag LLP on

Key Takeaways: The draft guidance represents the first-ever specific expectation by FDA that sponsors develop a diversity plan for trials. FDA’s recommendations come as part of increasing interest in ensuring clinical...more

Alston & Bird

Alston & Bird Health Care Week in Review - April 2022 #1

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more

Alston & Bird

Alston & Bird Health Care Week in Review - March 2022 #1

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more

Foley & Lardner LLP

March Is Here, so What’s Next in Washington?

Foley & Lardner LLP on

The first day of spring is right around the corner and so are deadlines for congressional appropriations requests. This month, lawmakers are racing against the clock to fund the government and President Biden looks to...more

Holland & Knight LLP

2022 Congressional Outlook and Top 10 Federal Health Policy Issues to Watch

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As Congress reconvenes, it faces a packed agenda in a legislative year that will be shortened by the upcoming midterm elections and remains buffeted by the persistent coronavirus pandemic. The list of healthcare priorities is...more

Bass, Berry & Sims PLC

HHS Reverses Trump Administration Restrictions on Fetal Tissue Research

Bass, Berry & Sims PLC on

On April 16, 2021, the Department of Health and Human Services (HHS) rescinded actions taken during the Trump administration regarding extramural research funded by the National Institutes of Health (NIH) involving human...more

K&L Gates LLP

Biden Administration Seeks to Establish New US$6.5 Billion Health Research Agency to Target Key Disease Areas

K&L Gates LLP on

On 9 April 2021, during a weekly economic briefing, President Biden announced his administration’s intent to establish and fund a new regulatory agency, named the Advanced Research Projects Agency for Health (ARPA-H), which...more

Jackson Lewis P.C.

COVID-19 Vaccination: Setting Up On-Site Programs

Jackson Lewis P.C. on

The Biden administration has called for all people at least 18 to be eligible for the COVID-19 vaccine by April 19, 2021. Most states have already done so. A BenefitsPro article cites a 2017 survey from the Society for...more

Faegre Drinker Biddle & Reath LLP

COVID-19 Weekly Newsletter: Vaccine Progress Continues in U.S.

With a vaccination rate of 49 doses administered per 100 people, the United States has administered a higher number of vaccines than any country in the world. As the federal government looks to keep the vaccine rollout...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, February 2021 # 9

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In Washington: House managers finished presenting their case against former President Trump at his impeachment trial on Thursday. They argued that Trump's statements prior to and at the January 6 "Stop the Steal" rally...more

Alston & Bird

Alston & Bird Health Care Week in Review - February 2021 #1

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more

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