In one of the most aggressive regulatory shake-ups in modern pharmaceutical history, the Commissioner's National Priority Voucher Pilot Program, or CNPV, can dramatically reduce approval times for new drug introductions....more
On December 23, 2025, the U.S. Department of Health and Human Services ("HHS") issued a request for information ("RFI") seeking input on ways it could accelerate the adoption and use of AI as a part of clinical care,...more
2/10/2026
/ Artificial Intelligence ,
Automated Decision Systems (ADS) ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Emerging Technologies ,
Health Care Providers ,
Healthcare ,
Innovation ,
Payment Systems ,
Regulatory Reform ,
Regulatory Requirements ,
Request For Information ,
Research and Development
The U.S. Food and Drug Administration ("FDA") recently issued updated final guidance documents on general wellness products and clinical decision support ("CDS") software, reflecting a pro-innovation and risk-based regulatory...more
1/28/2026
/ CDS ,
Digital Health ,
Final Guidance ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Information Technologies ,
Innovation ,
Medical Devices ,
Medical Software ,
New Guidance ,
Regulatory Oversight ,
Regulatory Requirements ,
Risk Management ,
Wellness Programs
A new Food and Drug Administration ("FDA") pilot opens the door for digital health devices without FDA premarket authorization to be used to provide care paid under the Center for Medicare and Medicaid Innovation ("CMMI")...more
12/19/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
CMMI ,
Digital Health ,
Enforcement Actions ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Healthcare ,
Medical Devices ,
Medicare ,
Pilot Programs ,
Regulatory Oversight ,
Regulatory Requirements ,
Risk Management
Pharmaceutical companies are increasingly concerned about the prospect that the Food and Drug Administration (FDA) will be delayed in its consideration of pending New Drug Applications (NDAs) and Biologics Licensing...more
10/1/2025
/ Administrative Procedure Act ,
Biologics ,
Executive Orders ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
Pharmaceutical Industry ,
Supply Chain ,
Tariffs ,
Trump Administration
Though every new presidential administration creates new challenges—and opportunities—for businesses, the second Trump administration has proven to be particularly eventful for the life sciences industry.
...more
10/1/2025
/ Administrative Procedure Act ,
Biologics ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Healthcare ,
Investigational New Drug Application (IND) ,
Judicial Review ,
Life Sciences ,
Mandamus Petitions ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Oversight ,
Statutory Deadlines ,
Statutory Interpretation ,
Trump Administration
The One Big Beautiful Bill Act ("OBBB") expands exemptions for orphan drugs from mandatory Medicare price negotiations and modifies their eligibility timeline....more
7/29/2025
/ Drug Pricing ,
Health Insurance ,
Healthcare ,
Medicare ,
New Legislation ,
One Big Beautiful Bill Act ,
Orphan Drugs ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Reform ,
Trump Administration
The Center for Medicare and Medicaid Innovation ("CMMI") is set to reshape value-based care. In the third of a three-part series highlighting this new direction, this summary is focused on CMMI's efforts regarding drugs,...more
6/13/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
CMMI ,
Data Collection ,
Data Management ,
Digital Health ,
Drug Pricing ,
Health Insurance ,
Healthcare ,
Healthcare Reform ,
Life Sciences ,
Medicaid ,
Medical Devices ,
Medicare ,
Patient Access ,
Pharmaceutical Industry ,
Value-Based Care
California Assembly Bill 1264 reflects continued state interest in restrictive legislation directed at the food and beverage industry and, in particular, food additives. ...more
3/31/2025
/ California ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Food Safety ,
Legislative Agendas ,
Proposed Legislation ,
Public Health ,
Public Schools ,
School Lunch Programs ,
State and Local Government ,
Students
Secretary Kennedy seeks to enhance FDA's oversight of food additives by eliminating a pathway that allows new ingredients to be introduced into the U.S. food supply without premarket notification to or approval by FDA....more
The Centers for Medicare and Medicaid Services ("CMS") published a final notice outlining the processes and procedures for the Transitional Coverage for Emerging Technologies ("TCET") pathway, a Medicare coverage pathway...more
While generative artificial intelligence ("GenAI") has the potential to fundamentally change health care, it presents unique risks and complexities that challenge the U.S. Food and Drug Administration's ("FDA" or "Agency")...more
As a streamlined method for obtaining U.S. Food and Drug Administration ("FDA") authorization of post-market functionality, FDA issued final guidance recommending the information to include in a Predetermined Change Control...more
12/27/2024
/ Artificial Intelligence ,
FDA Approval ,
Final Rules ,
Food and Drug Administration (FDA) ,
Healthcare ,
Innovative Technology ,
Life Sciences ,
Machine Learning ,
Medical Devices ,
New Guidance ,
Pharmaceutical Industry ,
Post-Market Approval ,
Regulatory Agenda
The U.S. Food and Drug Administration's ("FDA") new advisory committee on digital health is set to examine its approach for evaluating and regulating the safety and effectiveness of medical devices utilizing generative...more
The Food and Drug Administration ("FDA") recently issued its first warning letter to a domestic entity after conducting a remote regulatory assessment ("RRA"), indicating increased confidence and likely broader use of RRAs in...more
Building on CDER's efforts to modernize clinical trials, C3TI will support innovative approaches to clinical trial design and conduct....more
The U.S. Food and Drug Administration ("FDA") has proposed updated guidance, intended to assist individuals in meeting the cybersecurity requirements for FDA medical device submissions....more
Amending prior requirements, medical device manufacturers and importers have two years to comply with FDA's Quality Management System Regulation final rule, a similar approach to prior good manufacturing practices but with...more
The Food and Drug Administration ("FDA") recently issued revised draft guidance on remote regulatory assessments ("RRAs")—voluntary or mandatory examinations of food, drug, device, and tobacco establishments and/or their...more
2/22/2024
/ Comment Period ,
Draft Guidance ,
FDA Approval ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
Remote Proceedings
The Food and Drug Administration ("FDA") expands informed consent exceptions with a final rule permitting institutional review board ("IRB") waiver or alteration of elements for certain FDA-regulated minimal-risk clinical...more
With a November 2023 compliance deadline fast approaching, FDA publishes guidance explaining a one-year delayed enforcement of certain obligations, including interoperable, electronic, and package-level product tracing...more
9/25/2023
/ Drug Distribution ,
DSCSA ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
New Guidance ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Oversight ,
Supply Chain ,
Tracking Systems
Heralding the significant changes coming to the U.S. cosmetics industry starting in 2023, the U.S. Food and Drug Administration ("FDA") has issued draft guidance to companies regarding cosmetic facility registrations and...more
8/23/2023
/ Comment Period ,
Cosmetics ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Listing Rules ,
Manufacturers ,
Modernization of Cosmetics Regulation Act of 2022 (MoCRA) ,
Product Identifiers ,
Product Labels ,
Product Packaging ,
Registration Requirement
The National Institute of Standards and Technology ("NIST") has released its AI Risk Management Framework ("AI RMF") as a resource to reportedly assist individuals, organizations, and society identify risks associated with...more
In Short -
The Situation: With the calendar officially turned to a new year several significant changes and regulatory initiatives are on the horizon at the Food and Drug Administration ("FDA")....more
Under the proposed regulation, sponsors and sponsor-investigators whose planned study falls within an exemption will not be required to submit an Investigational New Drug application ("IND") or comply with IND reporting...more