FDA Will Drop Two-Study Requirement for New Drug Approvals, Aiming to Speed Access U.S News February 18, 2026 ...
The FDA guidelines aim to create a new pathway for bespoke therapies due to the challenges of conducting large studies.
A policy change allowing approval of some new drugs based on one adequate and well-controlled study could accelerate ...
This Sounding Board announces a new FDA policy that the default requirement for FDA approvals will be one robust pivotal trial plus confirmatory evidence, rather than two trials.
The FDA has proposed new guidelines to expedite the approval of customized treatments for rare diseases, creating a ...
FDA proposes a new system to approve customized drugs and therapies for rare diseases, enhancing treatment accessibility and innovation.
HealthDay News — US health officials are proposing a new way to develop and approve custom-made treatments for people with rare and hard-to-treat conditions.
"With the FDA recently saying too many [medical] devices are getting approved too easily and some other things they are articulating, it's frustrating," Montage Systems CEO Eric Collins said during a ...
Optune Pax® with the chemotherapy combination of gemcitabine and nab-paclitaxel is the first treatment to be FDA approved in nearly 30 years for locally advanced pancreatic cancer.
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