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
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
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
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
The advent of the COVID-19 rapid antigen test launched at-home diagnostics to the forefront of conversation in the life sciences industry. Many believe this is only the beginning. As the share of telehealth services...more
On February 22, 2024, FDA released a final guidance detailing how foods derived from genome-edited plants fall into FDA’s existing food safety framework and outlining two voluntary consultation processes for developers. The...more
Alongside rapid advances in biotechnology that are improving fine-tuned genetic engineering in plants, regulation for such plants is also rapidly evolving, including several important updates in the past year....more
The year 2023 was a busy one for regulatory, compliance, and enforcement developments in the healthcare and life sciences industries, and 2024 promises to be even busier. We tapped MoFo’s Life Sciences + Healthcare Compliance...more
1/10/2024
/ Anti-Kickback Statute ,
Antitrust Violations ,
Artificial Intelligence ,
CDRH ,
Cyber Attacks ,
Cybersecurity ,
Data Security ,
Department of Justice (DOJ) ,
Enforcement ,
Enforcement Actions ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Foreign Corrupt Practices Act (FCPA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare Fraud ,
Life Sciences ,
Medical Devices ,
OPDP ,
Popular ,
Ransomware ,
Securities and Exchange Commission (SEC)
The U.S. Department of Agriculture (USDA) and U.S. Patent and Trademark Office (USPTO) have recently opened requests for stakeholder engagement regarding biotechnology regulatory frameworks. These requests provide the...more
11/21/2023
/ Agricultural Sector ,
APHIS ,
Biotechnology ,
Comment Period ,
Environmental Protection Agency (EPA) ,
Federal Register ,
Food and Drug Administration (FDA) ,
Intellectual Property Protection ,
The Nagoya Protocol ,
USDA ,
USPTO
In the latest attempt to promote generic drug competition and reduce drug prices, and consistent with broader efforts to enforce the antitrust laws more aggressively, the Federal Trade Commission (FTC) announced on November...more
11/14/2023
/ Antitrust Division ,
Competition ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
FTC Act ,
Generic Drugs ,
Hatch-Waxman ,
Manufacturers ,
Orange Book ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Policy Statement
Last week, the U.S. Food and Drug Administration (FDA) published its new guidance on the Development and Licensure of Vaccines to Prevent COVID-19 (the “Guidance”). FDA provided a preview of a new COVID-19 vaccines guidance...more
On September 19, FDA released a highly anticipated new draft guidance for industry titled Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory...more
After much anticipation, the EU Commission’s proposal for a regulation on plants developed using New Genomic Techniques (NGTs) is now under consideration. For an overview of the EU proposal, please see MoFo’s recent post....more
7/3/2023
/ Agricultural Marketing Act ,
APHIS ,
Biotechnology ,
EU ,
Food and Drug Administration (FDA) ,
Genetically Engineered Seed ,
Life Sciences ,
Medical Foods ,
Pharmaceutical Industry ,
Plant Based Products ,
USDA
In the last ten years, more data and greater computing power have led to a boom in AI-related patent applications, with life and medical sciences emerging as a top application field. In 2021, more than 100 applications...more
6/16/2023
/ Artificial Intelligence ,
Biotechnology ,
Center for Drug Evaluation and Research (CDER) ,
Corporate Counsel ,
Emerging Technologies ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Machine Learning ,
PHI ,
Regulatory Agenda ,
Research and Development ,
State Privacy Laws ,
USDA
On Wednesday, May 10, 2023, the Food and Drug Administration (FDA) announced the publication of a new discussion paper titled “Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological...more
5/12/2023
/ Artificial Intelligence ,
Center for Drug Evaluation and Research (CDER) ,
Comment Period ,
Digital Health ,
Food and Drug Administration (FDA) ,
Governance Standards ,
Machine Learning ,
Medical Devices ,
National Evaluation System for Health Technology (NEST) ,
NIST ,
Transparency
On April 3, 2023, FDA released the draft guidance titled “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions”...more
This week, the U.S. Food & Drug Administration (FDA) issued two much anticipated guidances, each outlining how COVID-19 devices will be treated after the expiration of the COVID-19 public health emergency (PHE) declaration or...more
On Thursday, March 23, 2023, the Food and Drug Administration (FDA) announced the publication of the “Framework for the Use of Digital Health Technologies in Drug and Biological Product Development” (Framework) by the Center...more