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Life Sciences National Institute of Health (NIH) Pharmaceutical Industry

Latham & Watkins LLP

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

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

Faegre Drinker Biddle & Reath LLP

NIH Funding Guidance; FDA Reinstates Key Staff Amid Industry Pressure; Make America Healthy Again Commission; and the Latest on...

With the rapidly evolving regulatory landscape, staying on top of the latest updates is crucial for companies in biopharma and medical devices. In this briefing, we highlight recent regulatory and legislative developments...more

Skadden, Arps, Slate, Meagher & Flom LLP

Health Care: Trump Focuses on Drug Pricing Experiments, ACA and Research Grants

In his first week in office, President Donald Trump issued executive orders and took other actions with significant implications for the life sciences and health care industries that mark substantial departures from the...more

MoFo Life Sciences

Federal Court Invalidates Dosing Patent Based On Clinical Trials Disclosure

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As an essential component of the drug development process, human clinical trials assist in determining whether a given drug will serve its intended purpose, but patent applicants should consider disclosure of such trials in...more

Alston & Bird

Health Care Week in Review: House Held a Markup of 23 Bills; Senators Announced a Proposal on Primary Care Payment Reform

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

Alston & Bird

Health Care Week in Review: CMS Finalizes Rules on Nursing Home Staffing Standards and Medicaid Access and Quality; FTC Bans Most...

Alston & Bird on

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

Knobbe Martens

Reseller or Distributer Beware? Downstream Liability for Infringing a Patented Process

Knobbe Martens on

As retailers or distributors that are not manufacturers of a product, companies may believe they cannot infringe a patent claiming how the product is made. After all, the retailers or distributors are not performing any steps...more

MoFo Life Sciences

Senators Call For Report On State Of Psychedelic Research

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Earlier this month, Senators Brian Schatz (D-HI) and Cory Booker (D-NJ) sent a letter to the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) urging both agencies to advance research on the...more

Hogan Lovells

COVID-19 Report for Life Sciences and Health Care Companies - November 2021

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The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time. In this week's Report: U.S....more

Morgan Lewis - As Prescribed

Fourteen Years Later, FDA Flexes Its Clinicaltrials.gov Enforcement Authority

FDA recently issued its first clinicaltrials.gov notice of noncompliance to a clinical trial sponsor for failure to submit clinical trial results to the National Institutes of Health (NIH) databank. ...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, April 2021 # 4

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In Washington: The Consumer Financial Protection Bureau (CFPB) on Monday proposed a rule ordering debt collectors to inform tenants about their rights under a federal eviction ban if they’ve been unable to pay rent during the...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 17, Number 9. In This Month's E-News: September 2020

Report on Research Compliance 17, no. 9 (August 20, 2020) - The Office of Management and Budget has published guidance for agencies and recipients of federal awards and contracts, finalizing a document issued in February...more

Morgan Lewis

FDA COVID-19 Guidance Roundup for Drug and Biologics

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From the beginning of the coronavirus (COVID-19) pandemic, FDA actively provided guidance to members of the drug and biologic industries, including sponsors, investigators, pharmacies, and compounders....more

Bricker Graydon LLP

Clinical research flexibilities during the COVID-19 public health emergency

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Recognizing the significant effects that COVID-19 has had on clinical research, the federal government has issued multiple guidance documents related to clinical research flexibilities to support continued research during the...more

Health Care Compliance Association (HCCA)

From Remote Oversight to Wind-Downs: Research Struggles in the Time of COVID-19

Report on Research Compliance 17, no. 4 (April 2020) - “In an effort to minimize the risk of contracting or spreading COVID-19 in human participant research interactions and to preserve personal protective equipment for...more

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

Top experts, by failing to disclose conflicts of interest, shortchange taxpayers

Elite researchers — professors and staff with ties to 20 of the nation’s top universities and the respected National Institutes of Health — may be failing to be as candid as institutions and laws require about their potential...more

Troutman Pepper Locke

NIH May Own Gilead's Blockbuster Hepatitis Drug Due to Misstep

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Every year, the National Institutes of Health (NIH) spends billions of federal dollars on research and development of new drugs and therapies for treating and preventing serious illnesses....more

Morgan Lewis

21st Century Cures Act’s Effect on Pharmaceutical and Biotechnology Industries

Morgan Lewis on

The 21st Century Cures Act contains significant new mandates for both the FDA and NIH that affect the pharmaceutical and biotechnology industries and are intended to advance drug research, discovery, approval, and promotion...more

Skadden, Arps, Slate, Meagher & Flom LLP

The 21st Century Cures Act: FDA Reforms Aim to Spur Innovation in the Pharmaceutical, Medical Device and Health Research Sectors

On December 13, 2016, President Obama signed into law the 21st Century Cures Act (Act), one of the most important pieces of health care and life sciences legislation in several decades. The Act is intended to spur the rapid...more

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