News & Analysis as of

Office of Management and Budget Life Sciences

Pillsbury Winthrop Shaw Pittman LLP

Congress Sets Sights on Limiting Access to Chinese Biotech Companies

The BIOSECURE Act would prohibit federal agencies from contracting with, extending loans to, or awarding grants to, any company with existing or pending agreements with identified biotechnology companies. This limits funding...more

Lowenstein Sandler LLP

The BIOSECURE Act: Proposed New Legislation Could Affect U.S. Companies’ Plans to Contract With Chinese Biotechnology Companies

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The U.S. Senate and the U.S. House of Representatives are both considering legislation that could have a serious impact on the ability of U.S. biotechnology, drug, and medical device companies to do business with...more

Polsinelli

Biden’s October 30, 2023, Executive Order on AI: Key Takeaways for Health Care Stakeholders

Polsinelli on

The emergence of generative machine learning models, such as ChatGPT, has led to a surge in interest in artificial intelligence (“AI”) over the past year. This increased interest extends to the health care industry, where AI...more

Polsinelli

Fall Congressional Forecast: Eye on Federal Funding and Health Care

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Congress faces a crowded agenda this fall comprised of must-pass policy initiatives and potential political messaging opportunities in the lead up to the November midterm elections. With control of both chambers at stake, the...more

Epstein Becker & Green

Unpacking Averages: Assessing the Racial Composition of Drug Clinical Trial Subjects

The United States Food and Drug Administration (FDA) for many years has been trying to increase the participation of minorities in clinical trials to help ensure that regulated products are tested and labeled in an...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, May 2021 # 7

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In Washington: President Biden announced Monday that the U.S. will share an additional 20 million doses of domestically-authorized coronavirus vaccines with foreign countries by the end of June. The U.S. will export doses of...more

Morgan Lewis

Biden Leaves in Place Key Portions of Buy American Act Changes, Targets New Domestic End Product Test and Services

Morgan Lewis on

President Joe Biden issued on January 25 an Executive Order on Ensuring the Future Is Made in All of America by All of America's Workers (EO). This EO leaves in place key portions of the prior administration’s July 15, 2019...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

McDermott Will & Emery

Special Report - The Future of AI Regulation: The Government as Regulator and Research & Development Participant - Part 1 of 2

Artificial intelligence (AI) systems have raised concerns in the public—some speculative and some based in contemporary experience. Some of these concerns overlap with concerns about privacy of data, some relate to the...more

Mintz - Health Care Viewpoints

GAO Report Sheds Light on Drug Manufacturers’ Expanded Access Programs

Out of a sample of 29 non-representative drug manufacturers surveyed earlier this year, 23 had publicly posted policies related to accessing their investigational drugs outside of the context of formal clinical trials,...more

Hogan Lovells

New OMB review process could impede FDA issuance of guidance documents

Hogan Lovells on

Starting on 11 May 2019 there will be an additional layer of government review that may slow down the issuance of certain U.S. Food and Drug Administration (FDA) guidance documents. ...more

Foley & Lardner LLP

Trump's Proposed 2018 Budget Will Double FDA User Fees

Foley & Lardner LLP on

During his speech last month to a joint session of Congress, President Trump called out the U.S. Food and Drug Administration for its “slow and burdensome approval process.” Those comments came on the heels of Trump’s...more

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