Regulatory Oversight, Digital Health, Regulatory Agenda

Are FDA Review Timelines Slipping? What Companies Need to Know

Gardner Law on 5/30/2025

As noted in our earlier alert, the FDA continues to face mounting internal pressure, ranging from staffing reductions and document backlogs to operational restructuring. While core review functions are still running, early...more

Special Report: FDA 2019 Year in Review

McDermott Will & Emery on 1/14/2020

The US Food and Drug Administration’s (FDA’s) 2019 regulatory agenda focused on digital health, streamlined product approvals, evolving evidentiary thresholds for product approvals and strategic enforcement. The agency...more

FDA Year in Review: A Shifting Regulatory Landscape

Sheppard Mullin Richter & Hampton LLP on 1/8/2020

The FDA actions that dominated 2019 demonstrated a shifting regulatory landscape for certain product types, such as e-cigarettes, foods and supplements containing cannabidiol (CBD), and digital health / machine learning...more

Evolution & Revolution: Device Policy Priorities at FDA in 2019

Mintz - Health Care Viewpoints on 12/5/2019

This post is the first in a series of three in which we recap the Food and Drug Administration’s somewhat difficult year, having spent the majority of it without a permanent Commissioner and facing a slew of political and...more

FDA Proposes Pathway for Artificial Intelligence/Machine Learning Software

Stinson LLP on 4/11/2019

Last week, the FDA published a discussion paper outlining a proposed regulatory framework for artificial intelligence/machine learning software as a medical device (AI/ML SaMD)....more

FDA wants to hear from you: Proposed framework for regulating output of digital health tools accompanying prescription drugs as...

Hogan Lovells on 11/27/2018

On 20 November the Food and Drug Administration (FDA) published a request for comments on a proposed framework for regulating the output of digital health applications disseminated by or on behalf of drug manufacturers with...more