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Life Sciences National Institute of Health (NIH) Department of Health and Human Services (HHS)

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

Health Care Compliance Association (HCCA)

In This Month’s E-News: May 2024

Some funding applications submitted to NIH beginning Jan. 25 will face new requirements and undergo a revised peer review process. To prepare investigators and institutions, NIH launched a dedicated website with details about...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

Health Care Compliance Association (HCCA)

In This Month’s E-News: February 2024

The Food and Drug Administration (FDA) is seeking strategies from Jeffrey W. Taub, M.D., to prevent future violations of human subject regulations the agency said were documented during site visits in September and October...more

Alston & Bird

Health Care Week In Review: HRSA Releases List of Health Professional Shortage Areas, Biden Bolsters HHS Authority to Address Drug...

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

Health Care Compliance Association (HCCA)

Bucking History, ORI Deputy Denies Requests For Misconduct NPRM Comment Extension

Report on Research Compliance 20, no. 12  (December 2023) In a move that is unprecedented in recent memory, a federal agency has denied a request to extend the comment period on a substantive proposed rule, turning down a...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 19, Number 12. In This Month’s E-News: December 2022

The Council on Governmental Relations (COGR) is sounding an alarm regarding costs institutions have expended to comply with “new and clarified provisions calling for researchers to disclose all sources of research support and...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 19, Number 11. In This Month’s E-News: November 2022

NIH is unable to “ensure grants have appropriate cybersecurity provisions” and should make nearly a half-dozen changes, according to auditors for the HHS Office of Inspector General (OIG). Yet, NIH said it had already made...more

Alston & Bird

Alston & Bird Health Care Week in Review - March 2022 #3

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

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

Hogan Lovells

Coronavirus: The Hill and the Headlines, January 2021 # 15

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In Washington: House Democrats are altering the House calendar to speed up passing a COVID-19 relief through a reconciliation package by mid-March. House Majority Leader Steny Hoyer (D-MD) announced that the House will not...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

K&L Gates LLP

Sharing Clinical Trial Data: A New Era in Life Sciences Has Begun

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The European Medicine Agency’s (EMA) Policy on Publication of Clinical Data for Medicinal Products for Human Use (“EMA Policy”)is now effective as of January 1, 2015. Across the Atlantic, the U.S. Institute of Medicine (IOM)...more

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