The agency launched Elsa 4.0, a significant upgrade to the agency’s internal AI tool available to all FDA staff, from scientific reviewers to investigators. The agency also consolidated more than 40 ...
The Food and Drug Administration’s flagship internal AI tool, Elsa, is being integrated with the data platform so that staff ...
In one of his first major announcements as health secretary, Robert F. Kennedy Jr. called a news conference to unveil a plan ...
On April 23, 2026, the Centers for Medicare & Medicaid Services (CMS) and the Food and Drug Administration (FDA) announced “a new pathway designed ...
The Food and Drug Administration has announced some major changes to the review process for drug developers in the United States. It could cut down the time from 10 to 12 months for a review to just ...
The Food and Drug Administration (FDA) is set to pilot test real-time clinical trials in the hopes of expediting results and ...
Market opportunities include gaining a comprehensive understanding of FDA procedures for US pharmaceutical submissions, critical for navigating the largest global market. This course provides deep ...
On August 15, 2025, the U.S. Court of Appeals for the D.C. Circuit limited FDA's ability to deny a hearing on the approvability of a new drug application (NDA) based on a lack of “substantial evidence ...
The FDA is contemplating changing its medical device for software approval process, JD Supra reports. Here’s what you should know. 1. Software as a medical device applies to all software used to ...
In a set of newly released presentations, officials from the US Food and Drug Administration (FDA) explain changes to the agency's biomarker qualification program and detail early opportunities for ...
And FDA explains that they don’t have any extra. Congress has been underfunding FDA for decades, and the agency only stays afloat now by virtue of user fees the industry pays to get submissions ...
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