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
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
Building on CDER's efforts to modernize clinical trials, C3TI will support innovative approaches to clinical trial design and conduct....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The Food and Drug Administration ("FDA") recently issued revised draft guidance on remote regulatory assessments ("RRAs")—voluntary or mandatory examinations of food, drug, device, and tobacco establishments and/or their...more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Draft Guidance ,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
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