On February 23, 2026, the U.S. Food & Drug Administration (FDA) published a press announcement regarding a new draft guidance titled “Considerations for the Use of the Plausible Mechanism Framework to Develop Individualized...more
2/27/2026
/ Biologics ,
Biotechnology ,
Clinical Trials ,
CRISPR ,
Draft Guidance ,
Drug Approvals ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Investigational New Drug Application (IND) ,
Life Sciences ,
New Guidance ,
Orphan Drugs ,
Pharmaceutical Industry ,
Regulatory Oversight ,
Regulatory Requirements ,
Research and Development
AI tools in healthcare are no longer just boosting efficiency. They are reshaping how care is delivered, managed, and personalized. Below are the AI healthcare and medical device trends poised for major expansion in...more
1/29/2026
/ Artificial Intelligence ,
Centers for Medicare & Medicaid Services (CMS) ,
Cybersecurity ,
Digital Health ,
EHR ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Healthcare ,
Machine Learning ,
Medical Devices ,
Pharmaceutical Industry ,
Regulatory Oversight
The U.S. Food and Drug Administration (FDA) Human Foods Program (HFP) published its 2026 Priority Deliverables, outlining a broad agenda under the Trump administration’s Make America Healthy Again (MAHA) strategy to advance...more
1/27/2026
/ Food and Drug Administration (FDA) ,
Food Contamination ,
Food Labeling ,
Food Safety ,
GRAS ,
New Guidance ,
PFAS ,
Proposed Rules ,
Public Health ,
Regulatory Agenda ,
Regulatory Oversight ,
Regulatory Reform ,
Toxic Chemicals
Morrison Foerster partners Kate Driscoll and Nate Mendell, both former federal prosecutors and members of the firm’s Investigations + White Collar Defense Group, hosted the twelfth episode of When Your Life Sciences Are on...more
On January 7, 2026, the U.S. Department of Health and Human Services (“HHS”) and the U.S. Department of Agriculture (“USDA”) released the 2025–2030 Dietary Guidelines for Americans (“DGAs” or “Guidelines”), representing the...more
1/9/2026
/ Agribusiness ,
Department of Health and Human Services (HHS) ,
Dietary Guidelines ,
Dietary Supplements ,
Food Labeling ,
Food Manufacturers ,
Government Agencies ,
New Guidance ,
Public Health ,
School Lunch Programs ,
USDA
The BIOSECURE Act, which restricts the ability of U.S. executive agencies to contract with “Biotechnology Companies of Concern,” is now law. First introduced in the 2023-2024 legislative session and nearly passed into law...more
12/19/2025
/ BIOSECURE Act ,
Biosimilars ,
Biotechnology ,
Department of Defense (DOD) ,
Drug Pricing ,
Federal Acquisition Regulations (FAR) ,
Federal Contractors ,
Federal Funding ,
Government Agencies ,
Grants ,
Life Sciences ,
National Security ,
NDAA ,
New Legislation ,
Pharmaceutical Industry ,
Regulatory Requirements ,
Supply Chain
The BIOSECURE Act has returned in the 2025 legislative session in a new form as part of the Senate-passed version of the National Defense Authorization Act. The BIOSECURE Act (the “BIOSECURE Act” or the “Act”) was first...more
10/24/2025
/ Biotechnology ,
China ,
Department of Defense (DOD) ,
Department of Health and Human Services (HHS) ,
Federal Contractors ,
Government Agencies ,
National Security ,
NDAA ,
New Legislation ,
Pharmaceutical Industry ,
Popular ,
Proposed Legislation ,
Supply Chain
On September 23, 2025, the FDA published three new draft guidances that give insight into a regulatory framework for cell and gene therapies (CGTs) that is now coming into focus. By releasing these guidances together, FDA is...more
10/24/2025
/ Biologics ,
Biotechnology ,
Clinical Trials ,
Comment Period ,
Draft Guidance ,
Fast Track Process ,
Food and Drug Administration (FDA) ,
Life Sciences ,
New Guidance ,
Pharmaceutical Industry ,
Proposed Guidance ,
Public Comment ,
Regulatory Oversight ,
Regulatory Requirements ,
Research and Development
On September 9, 2025, the Make America Healthy Again Commission published the “Make Our Children Healthy Again Strategy Report”. The Report sets out more than 120 actions to reshape U.S. food policy and regulation,...more
9/16/2025
/ Department of Agriculture ,
Dietary Guidelines ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Food Marketing ,
Food Safety ,
GRAS ,
New Regulations ,
Nutrition Facts Labels ,
Proposed Rules ,
Public Health ,
Regulatory Reform ,
SNAP Program ,
USDA
On July 25, 2025, the U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) published a joint Request for Information (RFI) to solicit information and data to help the agencies develop a...more
7/31/2025
/ Comment Period ,
Consumer Protection Laws ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Food Safety ,
Food Supply ,
Proposed Rules ,
Public Health ,
Regulatory Agencies ,
USDA
As we reported in our recent client alert, the Trump administration has made clear that it is committed to using the False Claims Act (FCA) to prosecute healthcare fraud. Two recent Trump administration moves give important...more
7/21/2025
/ Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Electronic Medical Records ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud ,
Government Agencies ,
Health Care Providers ,
Healthcare Fraud ,
Investigations ,
Life Sciences ,
Medicare ,
Telehealth ,
Telemedicine ,
Trump Administration ,
Whistleblowers
2024 was a challenging year for M&A activity in the medical technology (“MedTech”) industry. Although some sectors experienced a rebound in deal volume, MedTech dealmakers were disproportionately affected by a difficult...more
7/14/2025
/ Acquisitions ,
Artificial Intelligence ,
Digital Health ,
Health Technology ,
Healthcare ,
Innovation ,
Investment ,
Medical Devices ,
Mergers ,
Private Equity ,
Regulatory Requirements ,
Technology ,
Technology Sector
On May 22, 2025, President Trump’s Make America Healthy Again (MAHA) Commission released an assessment titled “The MAHA Report: Make Our Children Healthy Again Assessment.” The report—framed as a “call to action”—stems from a...more
5/27/2025
/ Agricultural Sector ,
Artificial Intelligence ,
Chemicals ,
Clinical Trials ,
Environmental Policies ,
Food and Drug Administration (FDA) ,
Food Safety ,
Healthcare Reform ,
National Institute of Health (NIH) ,
Pesticides ,
Popular ,
Public Health ,
Regulatory Reform ,
Trump Administration
Transparency of artificial intelligence (AI) systems in healthcare is quickly becoming a central concern for regulators due to potential impacts on patient safety, healthcare quality, bias mitigation, and public trust. To...more
4/29/2025
/ AI Act ,
Algorithms ,
Artificial Intelligence ,
EU ,
Final Rules ,
Food and Drug Administration (FDA) ,
Health Information Technologies ,
Healthcare ,
ONC ,
Regulatory Requirements ,
Transparency
On April 22, 2025, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) announced a major initiative to voluntarily phase out “petroleum-based synthetic dyes” (i.e., synthetic...more
On March 10, the U.S. Department of Health and Human Services (HHS) issued a press release emphasizing “radical transparency to make sure all Americans know what is in their food” and announcing that HHS Secretary Robert F....more
In 2024, as in years past, healthcare fraud enforcement by the U.S. Department of Justice (DOJ) was substantial. Federal actions under the False Claims Act (FCA) alone resulted in $1.67 billion in settlements and judgments...more
1/28/2025
/ Compliance ,
Cybersecurity ,
Data Privacy ,
Department of Defense (DOD) ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Healthcare Fraud ,
Life Sciences ,
Medical Devices ,
NASA ,
Personally Identifiable Information ,
Private Equity ,
Qui Tam ,
Trump Administration ,
Venture Capital ,
Voluntary Disclosure ,
Whistleblowers
The Department of Justice published its False Claims Act (FCA) statistics for Fiscal Year 2024 this month, revealing a nearly 40% increase in whistleblower filings, increased recoveries year over year, and a near record...more
1/22/2025
/ Anti-Kickback Statute ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Federal Contractors ,
Healthcare Fraud ,
Medicaid ,
Paycheck Protection Program (PPP) ,
Qui Tam ,
Settlement ,
State Attorneys General ,
Whistleblowers
This post is part of MoFo’s 2025 Intersection of AI and Life Sciences blog series. In this blog series, we explore how artificial intelligence is revolutionizing research, innovation, and patient care in the life sciences....more
1/22/2025
/ Artificial Intelligence ,
Cybersecurity ,
Draft Guidance ,
Emerging Technologies ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Medical Devices ,
Regulatory Requirements ,
Risk Management ,
Software ,
Transparency
This post is part of MoFo’s 2025 Intersection of AI and Life Sciences blog series. In this blog series, we explore how artificial intelligence is revolutionizing research, innovation, and patient care in the life sciences....more
1/17/2025
/ Artificial Intelligence ,
Compliance ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Machine Learning ,
Medical Devices ,
Pharmaceutical Industry ,
Regulatory Agenda ,
Regulatory Requirements ,
Risk Management
On January 6, 2024, the U.S. Food and Drug Administration (FDA) issued its final guidance establishing action levels for lead in processed food intended for babies and young children. This is the first FDA guidance directly...more
1/13/2025
/ Baby Products ,
Class Action ,
Compliance ,
Consumer Protection Laws ,
Enforcement Actions ,
Final Rules ,
Food and Drug Administration (FDA) ,
Food Safety ,
Lead ,
Liability ,
Manufacturers ,
Product Defects ,
Public Health ,
Regulatory Requirements ,
Risk Mitigation ,
Toxic Chemicals
Yesterday, FDA released the final rule that updates the definition for “healthy” nutrient content claims. In an update that may be long overdue, manufacturers who use the term “healthy” (or derivative terms: “health,”...more
UPDATE: The stop-gap spending bill has been revised to remove the provision discussed herein. However, life sciences companies should nonetheless take note of efforts by congress to enact patent-related reforms such as this....more
Patent term extension (PTE) under 35 U.S.C. § 156 is a statutory program that restores to a patent at least a portion of the term that was effectively lost while the covered product was undergoing regulatory review and could...more
After overhauling its biotechnology regulations for plants developed using genetic engineering, the United States Department of Agriculture’s Animal and Plant Health Inspection Service (USDA-APHIS) is again reevaluating its...more