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 ...
Pharmaceutical Commerce

FDA Shifts Toward Single Trial Requirement for New Drug Approvals

A policy change allowing approval of some new drugs based on one adequate and well-controlled study could accelerate ...

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.

FDA unveils proposal for streamlined approval of customized drugs for rare diseases

The FDA has proposed new guidelines to expedite the approval of customized treatments for rare diseases, creating a streamlined pathway for bespoke therapies that could address unmet medical needs.