PharmExec

FDA Removes Two Study Requirement for New Drug Approval Process: Report

FDA Will Drop Two-Study Requirement for New Drug Approvals, Aiming to Speed Access U.S News February 18, 2026 ...
The American Journal of Managed Care

FDA Will Require Only 1 Study to Approve New Drugs, Speeding Up Process

This move is another step in Makary’s attempts to shorten FDA reviews, which started when he began his tenure last year. 3 These include mandating the use of artificial intelligence for staffers and ...

FDA proposes new system for approving customized drugs and therapies for rare diseases

The FDA guidelines aim to create a new pathway for bespoke therapies due to the challenges of conducting large studies.
Fierce Biotech

'Like talking to a brick wall': Senate hearing takes aim at FDA's rare disease review process

A panel of physicians, biotech leaders and patient advocates took aim at the FDA during a Senate hearing Thursday on how the ...
Infectious Disease Advisor

FDA Moves Toward Faster Drug Approvals

In a major shift, the US Food and Drug Administration is relaxing a long-standing drug approval requirement for common diseases.
Medical News Today

What does FDA approval mean? A guide to understand the process

FDA approval describes when the Food and Drug Administration (FDA) deems a medical product safe and effective for its intended use based on scientific data and testing. Before people use a medical ...
Infectious Disease Advisor

New FDA Proposal Aims to Help Patients With Hard-to-Treat Diseases

US health officials are proposing a new way to develop and approve custom-made treatments for people with rare and hard-to-treat conditions.
MobiHealthNews

FDA approval process too slow for wireless health

Montage is still awaiting FDA approval of its Wireless Healthphone, which is meant to send patient data wirelessly to doctors and other caregivers. Healthphone includes blood glucose monitoring ...