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Return of the BIOSECURE Act: What Life Sciences Companies Need to Know

Key Takeaways : House advances BIOSECURE Act as part of NDAA legislation. The latest version would bar contractors and federal funding recipients from using certain biotechnology equipment or services linked to foreign...more

New FDA Guidance Could Speed Biosimilar Approvals and Cut Costs

Key Takeaways: The FDA released draft guidance indicating it may approve certain biosimilars without requiring a comparative efficacy study (CES), traditionally a costly and time-intensive step....more

Revolutionary FAR Overhaul: Part 8 Rewrite

Key Takeaways: FAR Part 8 has been revised as part of the FAR Council’s ongoing “Revolutionary FAR Overhaul,” with agencies implementing changes now via class deviations, with formal rulemaking to follow....more

Navigating the Grantmaking Maze: A New Federal Oversight Framework

In a significant move to reshape the landscape of federal grantmaking, the recently issued Executive Order, “Improving Oversight of Federal Grantmaking,” is poised to transform how federal agencies administer grants. With the...more

Vive la revolution? The Trump Administration Begins to Roll Out its Overhauled FAR

Key Takeaways: The “Revolutionary FAR Overhaul” (RFO) represents the first major update to the Federal Acquisition Regulations (FAR) in four decades, intended to modernize the regulation by simplifying its language and...more

Supreme Court Halts Nationwide Injunctions with Major Implications for Ongoing Litigation

On June 27, 2025, the U.S. Supreme Court held, in a 6-3 decision in Trump v. Casa, that federal courts lack the authority to issue nationwide injunctions under the Judiciary Act of 1789 (Judiciary Act). In doing so, the Court...more

Trump Administration Announces New Executive Order to Promote Domestic Production of Biopharmaceuticals

Key Takeaways - Regulatory Relief for U.S. Manufacturing: The EO streamlines FDA and EPA processes to encourage domestic pharmaceutical production....more

Drug Pricing and Payment Executive Order Shows Trump Administration’s Cards

On April 15, 2025, President Trump signed the Lowering Drug Prices by Once Again Putting Americans First Executive Order (Executive Order). The Executive Order revives and expands several pharmaceutical pricing and payment...more

Incoming Defense Contract Audit Agency Reorganization

On April 7, 2025, the Defense Contract Audit Agency (DCAA) announced a comprehensive reorganization plan aimed at consolidating its Region and Corporate Audit Directorates (CAD) into three primary Directorates in response to...more

SCOTUS Ruling: Freezing $65 Million in Teacher Grants Amid DEI Controversy

On April 4, 2025, the United States Supreme Court granted an emergency application to vacate the First Circuit Court of Appeals’ March 10 temporary restraining order (TRO) in the case of Department of Education v. California....more

GSA Expansion under Executive Order “Eliminating Waste and Saving Taxpayer Dollars by Consolidating Procurement"

On March 20, 2025, President Trump issued an Executive Order (the “Order”) targeted at consolidating domestic government procurement processes. Titled “Eliminating Waste and Saving Taxpayer Dollars by Consolidating...more

HHS Job Cuts: FDA, CDC, NIH and CMS Impacted Amidst Significant Restructurings

On March 27, 2025, the United States Department of Health and Human Services (HHS) announced a “dramatic restructuring” that will result in a reduction in agency workforce combined with significant internal restructuring. The...more

CMMC 2.0: Department of Defense Publishes Final Rule to Establish its Cybersecurity Maturity Model Certification 2.0 Program

After years in the making, on October 15, 2024, the U.S. Department of Defense (DoD) published its final rule to establish the Cybersecurity Maturity Model Certification (CMMC) Program, amending Title 32 of the Code of...more

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