An expiring FDA program designed to incentivize research in pediatric rare disease may see new life. The Pediatric Rare Disease Priority Review Voucher (RPD PRV) provides sponsors of granted new marketing applications for...more
2/3/2026
/ Biotechnology ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
New Legislation ,
Pediatrics ,
Pharmaceutical Industry ,
Prescription Drugs ,
Priority Review Vouchers ,
Public Health ,
Regulatory Authority ,
Regulatory Oversight ,
Regulatory Requirements ,
Research and Development ,
Statutory Authority
On Jan. 14, 2026, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) jointly released the “Guiding Principles of Good AI Practice in Drug Development,” a set of 10 high-level principles...more
1/27/2026
/ Artificial Intelligence ,
Best Practices ,
Biotechnology ,
Cybersecurity ,
Data Management ,
Emerging Technologies ,
European Medicines Agency (EMA) ,
Food and Drug Administration (FDA) ,
Guidance Documents ,
New Guidance ,
Pharmaceutical Industry ,
Regulatory Oversight ,
Risk Management
The FDA’s January 2026 update to its “General Wellness: Policy for Low Risk Devices” guidance materially expands the types of wearable features that may avoid medical device regulation. Signaling a more flexible regulatory...more
1/12/2026
/ Digital Health ,
Enforcement Actions ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
General Wellness Devices ,
Guidance Documents ,
Manufacturers ,
Medical Devices ,
New Guidance ,
Regulatory Oversight ,
Regulatory Requirements ,
Risk Management ,
Wearable Technology
The market for maternal healthcare offers providers, payors and investors an opportunity to address pressing social needs while unlocking business growth and expansion. U.S. maternal mortality remains unacceptably high while...more
1/7/2026
/ Alternative Payment Models (APM) ,
Artificial Intelligence ,
Digital Health ,
Health Care Providers ,
Health Insurance ,
Healthcare Costs ,
Investors ,
Machine Learning ,
Medicaid ,
Popular ,
Privacy Laws ,
Regulatory Requirements ,
Reproductive Healthcare Issues ,
Telehealth ,
Telemedicine ,
Value-Based Care
President Donald Trump’s Dec. 18, 2025, executive order “Increasing Medical Marijuana and Cannabidiol Research” directs the Attorney General to “take all necessary steps” to move marijuana from Schedule I to Schedule III...more
12/23/2025
/ Cannabis Products ,
Controlled Substances Act ,
DEA ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Hemp ,
Internal Revenue Code (IRC) ,
Life Sciences ,
Marijuana ,
Medical Marijuana ,
Patient Access ,
Public Health ,
Rulemaking Process ,
Trump Administration
Food and beverage companies face mounting scrutiny over absolute marketing claims emphasizing the product’s purity. Terms such as “all natural,” “non-artificial,” “additive free” or “100% pure” may resonate with consumers,...more
Women’s healthcare during menopause and midlife, a once neglected sector, is experiencing unprecedented growth, fueled by increased awareness, consumer demand, innovation in clinical care and a surge in investment activity....more
On June 4, 2025, the U.S. Food and Drug Administration issued a public advisory urging consumers not to inhale nitrous oxide (N2O) from commercial dispensers, including canisters, tanks and portable chargers. The advisory...more
The McGuireWoods Healthcare Private Equity and Finance Conference brings together leading investors, operators and advisers to explore trends shaping the healthcare dealmaking landscape. With a focus on actionable insights...more
On March 31, 2025, the U.S. District Court for the Eastern District of Texas, in American Clinical Laboratory Association v. U.S. Food and Drug Administration, vacated the U.S. Food and Drug Administration’s (FDA’s) May 6,...more
On March 6, 2025, federal prosecutors charged a Minnesota couple — Gabriel Adam Alexander Luthor and Elizabeth Christine Brown — with orchestrating a $15 million healthcare fraud scheme involving overbilling and submission of...more
On March 24, 2025, West Virginia Gov. Patrick Morrisey signed House Bill 2354 into law, prohibiting the sale and distribution of food products with certain artificial food dyes and chemicals. The signing of HB 2354 means West...more
On Feb. 18, 2025, the U.S. Court of Appeals for the First Circuit adopted the “but for” causality standard for violations of the federal Anti-Kickback Statute (AKS) that give rise to violations of the federal False Claims Act...more
Across the United States, nitrous oxide (N2O), also known as laughing gas or nitrous, continues to be sold in convenience stores, gas stations and other easy-to-access locations with limited national enforcement. N2O serves a...more
The U.S. Food and Drug Administration (FDA) recently issued two new guidance documents governing details of the Accelerated Approval Program, including a focus on product withdrawal and requirements for ongoing confirmatory...more
In response to increased cybersecurity threats and significant regulatory enforcement actions, on Dec. 27, 2024, the Department of Health and Human Services (HHS) issued a Notice of Proposed Rulemaking seeking to enhance...more
On Jan. 15, 2025, the U.S. Food and Drug Administration revoked its authorization for the use of Red Dye No. 3 in food and ingested medications. Red Dye No. 3, chemically known as erythrosine, is a synthetic color additive...more
In response to an outbreak of the H5N1 strain of bird flu among dairy cows in at least 15 states, the U.S. Department of Agriculture (USDA) issued a new federal order (the Order) requiring dairy farms and other entities...more
Over 200 fellow healthcare leaders joined the 17th Annual Healthcare Finance and Growth conference for interactive programming discussing the latest developments in the industry and the challenges the industry faces in 2024...more
California and Missouri are the latest states to target hemp-based products containing intoxicating cannabinoids. On Sept. 23, 2024, California signed into law emergency regulations aimed at protecting children from the...more
The U.S. Cybersecurity & Infrastructure Security Agency has deemed healthcare entities “target rich, cyber poor,” meaning they have copious amounts of consumer and patient data but often do not have the cybersecurity means to...more
Applicable Provider Types: All -
Is Your Entity in Compliance?
The Health Insurance Portability and Accountability Act of 1996, as modified by the Health Information Technology for Economic and Clinical Health Act of 2009...more
5/29/2024
/ Business Associates ,
Business Associates Agreement (BAA) ,
Covered Entities ,
Cybersecurity ,
Data Breach ,
Data Privacy ,
Data Protection ,
Data Security ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
PHI ,
Popular
Applicable Provider Types: All -
Is Your Entity in Compliance?
The Health Insurance Portability and Accountability Act of 1996, as modified by the Health Information Technology for Economic and Clinical Health Act of...more
Applicable Provider Types: All -
Is Your Entity in Compliance?
The Health Insurance Portability and Accountability Act of 1996, as modified by the Health Information Technology for Economic and Clinical Health Act of 2009...more
Applicable Provider Types: All -
Is Your Entity in Compliance?
The Health Insurance Portability and Accountability Act of 1996, as modified by the Health Information Technology for Economic and Clinical Health Act of...more