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DEI executive order compliance checklist

Since his inauguration in January, President Trump has signed multiple executive orders addressing diversity, equity, and inclusion (DEI) policies across the country. These actions have significant implications, including for...more

HHS rescinds policy regarding notice-and-comment rulemaking – implications for health care industry

On February 28, 2025, the Department of Health and Human Services (“HHS” or “the Department”) issued a Policy Statement rescinding long-standing HHS guidance regarding the use of notice-and-comment rulemaking to adopt certain...more

New executive order ends contractor race and sex affirmative action obligations and targets employer DEI efforts

President Donald J. Trump on Tuesday issued a sweeping Executive Order (the Order), entitled “Ending Illegal Discrimination and Restoring Merit-Based Opportunity,” which impacts Federal contractors and grantees as well as...more

BIOSECURE stalls, will not become law in 2024

Earlier this week, efforts to reduce U.S. reliance on biotechnology companies in China stalled when the BIOSECURE Act (“BIOSECURE” or the “Act”) was left out of this week’s continuing resolution (CR). As a result, BIOSECURE...more

12/24/2024  /  Biotechnology , China , National Security , NDAA

CMS Issues Final Guidance on IRA 2027 Drug Price Negotiation Program, 2026-27 MFP Effectuation

On October 2, 2024, the Centers for Medicare & Medicaid Services (CMS) issued final guidance for initial price applicability year (IPAY) 2027 of the Drug Price Negotiation Program established by the Inflation Reduction Act...more

Life Sciences Procurement Update: FY2025 NDAA Would Changes to Rules of Origin for Drugs

In July, the Senate Armed Services Committee passed its version of the FY 2025 National Defense Authorization Act (NDAA), which would make substantial changes to the rules for determining the “country of origin” of drugs for...more

U.S. BIOSECURE Act: Key considerations for global cell, tissue, and gene therapy stakeholders

Efforts to curtail U.S. reliance on biotechnology companies in the People’s Republic of China (PRC) and prevent certain data of U.S. persons from being provided to the Chinese Communist Party (CCP) have come to the fore this...more

U.S. Department of Commerce issues new resource to facilitate antiboycott compliance

On 28 March, the U.S. Commerce Department, Bureau of Industry and Security (BIS) published a list of entities that have been identified as having made a boycott-related request in order to help U.S. companies, including...more

Biden Administration invites comments on new march-in rights framework

On Friday, December 8, the U.S. Department of Commerce's National Institute of Standards and Technology (NIST) opened for public comment its Draft Interagency Guidance Framework for Considering the Exercise of March-in...more

Federal Grants & Buy America: OMB issues final guidance for federally funded infrastructure projects

On August 23, 2023, the White House Office of Management and Budget (OMB) issued its final guidance (“Guidance”) implementing the Build America, Buy America (BABA) provisions of the Infrastructure Investment and Jobs Act...more

CMS Issues Final Guidance on the Inflation Reduction Act (IRA) Drug Price Negotiation Program

On July 3, 2023, the Centers for Medicare & Medicaid Services (CMS) issued its final guidance on the Drug Price Negotiation Program established by the IRA. CMS showed some willingness to adopt stakeholder suggestions...more

U.S. government bans the use of TikTok under government contracts

On June 2, 2023, the U.S. Government issued an interim rule that bans the use of the popular social media application, TikTok, from government contracting. The Department of Defense (DoD), General Services Administration...more

Federal Grants & Buy America: OMB Proposes Requirements for Federally Funded Infrastructure Projects

In February, the Office of Management and Budget (OMB) proposed new Buy America regulations for Federal grants, to implement the Build America, Buy America (BABA) Act signed into law on November 15, 2021. BABA required that...more

CMS issues initial guidance on Drug Price Negotiation Program

On March 15, 2023, the Centers for Medicare & Medicaid Services (CMS) issued initial guidance on the Drug Price Negotiation Program, which was established under the Inflation Reduction Act (IRA) on August 16, 2022. The Drug...more

Buy American final rule: March 7 amendment

On 7 March 2022, the Federal Acquisition Regulation (FAR) Council published a final rule amending the FAR to implement a January 2021 Executive Order (EO), EO 14005, aimed to strengthen domestic preferences in Government...more

Task Force provides some flexibility for federal contractors regarding vaccine mandate requirements

On November 1, 2021, the Biden Administration issued several new frequently asked questions (FAQs) for federal contractors subject to the President’s executive order mandating COVID-19 vaccinations for covered contractor...more

Task Force announces details of federal contractor vaccine mandate

The Safer Federal Workforce Task Force (Task Force) has issued its guidance (Guidance) regarding the COVID-19 safety protocols that federal contractors must implement under President Biden’s recent Executive Order 14042. The...more

New COVID-19 Executive Order Expands Requirements for U.S. Government Contractors

Late last week, in the latest step to curb the COVID-19 pandemic, President Joseph R. Biden announced new Federal contractor employee vaccination requirements that are set to go into effect as of 15 October. The...more

White House announces COVID-19 safety measures for onsite federal contractors

On 29 July 2021, the Biden Administration announced a wave of White House programs to boost vaccination rates in the United States, including programs aimed directly at federal contractors. These initiatives, summarized in a...more

Proposed rule seeks to significantly strengthen U.S. Government “Buy American” requirements

On 30 July 2021, the FAR Council published a proposed rule to significantly strengthen “Buy American” requirements applicable to goods sold to the U.S. Government. The proposed rule promotes the procurement of goods,...more

Aerospace & Defense Insights | Domestic sourcing guidance issued to help American businesses compete

Through Aerospace & Defense Insights, we share with you the top legal and political issues affecting the aerospace and defense (A&D) industry. Our A&D industry team monitors the latest developments to help our clients stay in...more

Domestic sourcing guidance issued to help American businesses compete

Last week, the White House Office of Management and Budget issued guidance to federal agencies implementing a January executive order that aimed to strengthen American industry through changes to federal contract law that...more

Biden Administration Releases First 100-Day Review, Spurring Immediate Actions for US Supply Chains

Pursuant to Executive Order 14017, issued by President Biden on 24 February 2021, a federal government task force examined the vulnerabilities in America’s supply chains for semiconductor manufacturing and advanced packaging,...more

Biden Administration supports waiver of WTO IP rights for COVID-19: Next steps for innovators

On 5 May 2021, U.S. Trade Representative Katherine Tai announced that the Biden Administration would support India and South Africa’s request for a World Trade Organization (WTO) waiver of intellectual property (IP) rights...more

Life Sciences and Health Care Horizons - 2021

Companies in the life sciences and health care industry, like most companies, navigated unparalleled challenges in 2020. But unlike other industries, they had to do so while simultaneously facing the biggest challenge of all...more

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