The final FY 2026 National Defense Authorization Act (NDAA) was released on December 7, inclusive of a modified version of the Senate-passed BIOSECURE Act from October. This final bill maintains the core structure of the...more
The final FY 2026 National Defense Authorization Act (NDAA) was released on December 7, inclusive of a modified version of the Senate-passed BIOSECURE Act from October. This final bill maintains the core structure of the...more
On November 20, 2025, at a closed-door, Q&A webinar on the proposed BIOSECURE Act, Joy Sturm, partner in the Hogan Lovells government contracts practice, led a conversation with a group of colleagues within various HL...more
11/26/2025
/ Biotechnology ,
China ,
Department of Justice (DOJ) ,
Export Controls ,
Federal Acquisition Regulations (FAR) ,
Federal Contractors ,
Geopolitical Risks ,
Healthcare ,
Life Sciences ,
National Security ,
Proposed Legislation ,
Supply Chain
On October 9, the U.S. Senate adopted amendment 3841, adding Section 881, Prohibition on Contracting with Certain Biotechnology Providers, a version of the BIOSECURE Act, to its version of the FY 2026 National Defense...more
10/27/2025
/ BIOSECURE Act ,
Biotechnology ,
China ,
Department of Defense (DOD) ,
Federal Acquisition Regulations (FAR) ,
Federal Contractors ,
Healthcare ,
National Security ,
NDAA ,
OMB ,
Pharmaceutical Industry ,
Procurement Guidelines ,
Supply Chain
On Wednesday, the U.S. Food and Drug Administration (FDA) published three new draft guidances that aim to offer greater clarity to sponsors of cell and gene therapies (CGTs) on issues related to clinical trial design,...more
9/26/2025
/ Center for Biologics Evaluation and Research (CBER) ,
Clinical Trials ,
Draft Guidance ,
Expedited FDA Approval ,
Food and Drug Administration (FDA) ,
Genetic Materials ,
Healthcare ,
Life Sciences ,
Orphan Drugs ,
Pharmaceutical Industry ,
Real World Evidence ,
Regenerative Medicine ,
Regulatory Requirements
The U.S. Food and Drug Administration (FDA) announced a new process called “Rare Disease Evidence Principles” (RDEP), under which eligible drugs and biologics for ultra-rare diseases caused by known genetic defects will...more
9/8/2025
/ Biologics ,
Biotechnology ,
Clinical Trials ,
FDA Approval ,
Healthcare ,
Life Sciences ,
Medical Research ,
Patient Access ,
Pharmaceutical Industry ,
Regulatory Oversight ,
Regulatory Reform ,
Regulatory Requirements ,
Research and Development
In 2025, Life Sciences and Health Care (LS&HC) companies face rapidly evolving regulatory paradigms that create transactional risks and require daily monitoring. After more than 70 national elections in 2024, the dust hasn’t...more
8/25/2025
/ Artificial Intelligence ,
Clinical Trials ,
Cybersecurity ,
Digital Health ,
Environmental Social & Governance (ESG) ,
Genetic Materials ,
Government Agencies ,
Healthcare ,
Healthcare Reform ,
Innovative Technology ,
Life Sciences ,
Pharmaceutical Industry ,
Public Health ,
Regulatory Oversight ,
Regulatory Reform ,
Regulatory Requirements ,
Risk Management ,
Supply Chain ,
Trump Administration
On May 5, 2025, President Donald Trump signed an Executive Order (EO) aiming to promote American-made prescription drugs (“Reshoring Manufacturing EO”). The EO directs federal agencies to eliminate regulatory hurdles,...more
Investments in new (“greenfield”) or expanded (“brownfield,” “retrofit”) domestic manufacturing capabilities require years of strategic planning and capital expenditure. Even with the announcement of near-term incentives and...more
The U.S. Department of Justice (DOJ) has finalized its rule on “Preventing Access to U.S. Sensitive Personal Data and Government-Related Data by Countries of Concern or Covered Persons,” which restricts data brokerage...more
The Department of Justice (DOJ) has issued a final rule limiting data transfers to China, Russia, and other designated “countries of concern.” The rule establishes a new national security program that bans specific types of...more
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
The U.S. Court of Appeals for the Ninth Circuit on Friday reversed the district court’s judgment in United States v. California Stem Cell Treatment Center, siding with the U.S. Food and Drug Administration (FDA) in finding...more
The U.S. Food and Drug Administration (FDA) has issued draft guidance on its “Platform Technology Designation Program,” which aims to streamline drug development, manufacturing, and marketing application review for products...more
FDA has recently increased its efforts to support the development and approval of cell, tissue, and gene therapy (CTGT) products. This is evidenced by the upswing in CTGT approvals in the last few years and the unprecedented...more
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
Gene editing (GE) therapies hold immense promise for treating a myriad of diseases. Like most novel products, their development and regulatory approval necessitate careful consideration of critical factors. FDA officials...more
Innovative technologies are reshaping every industry, presenting new business cases and changing our daily lives. These technologies are hyper-connecting the world and offering new ways to interact. Particularly in the Space...more
Last week, the U.S. Food and Drug Administration (FDA) proposed two new rules for classification of certain, previously unclassified wound dressings and liquid wound washes containing antimicrobials, which would categorize...more
On September 29, 2023, the U.S. Food and Drug Administration (FDA or "agency") announced the opportunity for a limited number of sponsors to participate in a new pilot program called Support for clinical Trials Advancing Rare...more
On March 10, 2023, the U.S. Food and Drug Administration (FDA) issued a Notice summarizing which of the agency’s COVID-19-related guidance documents will be rescinded and which will be revised to temporarily remain in effect,...more
Last year, a federal court in California ruled against the U.S. Food and Drug Administration (FDA) in a matter where the government alleged that a stem cell clinic’s products should be regulated as new drugs. The decision...more
Now that FDA’s grace period for regenerative medicines has ended, many manufacturers of human cell, tissue, or cellular- or tissue-based products (HCT/Ps) will be required to file a biologics license application (BLA) with...more
California’s Pharmaceutical and Sharps Waste Stewardship Act requires pharmaceutical companies doing business in the state to develop and submit a “stewardship plan” to CalRecycle, a branch of the state’s Environmental...more
Speaking at the World Stem Cell Summit hosted by the Regenerative Medicine Foundation, Hogan Lovells partners Mike Druckman, Ernesto Algaba, Mandi Jacobson, Lu Zhou, Mikael Salmela, Charlotte Damiano, and Lowell Zeta, along...more