Healio

FDA provides new approval process for rare disease therapies without large clinical trials

Please provide your email address to receive an email when new articles are posted on . The pathway aims to streamline approval for individualized treatments for rare and ultra-rare diseases. An ...
JD Supra

New FDA Guidance Aims to Simplify the Biosimilar Approval Process

In a new draft guidance, issued on October 29, 2025, the FDA proposed major updates to simplify biosimilarity studies and potentially reduce clinical testing for therapeutic protein products. The ...
Penn Live

Gene editing treatments could get easier FDA approval under new plan

WASHINGTON (AP) — Federal health officials on Monday laid out a proposal to spur development of customized treatments for patients with hard-to-treat diseases, including for rare genetic conditions ...
National Academies of Sciences%2c Engineering%2c and Medicine

Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years

As noted in Chapter 1, the committee was charged by the Food and Drug Administration (FDA) to review the 510(k) clearance process and answer two principal questions: Does the current 510(k) clearance ...