FDA says exploring how artificial intelligence can play a role in its regulatory operations is a top strategic goal of its just-released four-year inf...
FDA publishes draft guidances to support clinical and non-clinical testing in premarket submissions for medical devices with a weight loss indication.
The Federal Trade Commission issues a policy statement, which is supported by FDA, warning brand-name pharmaceutical companies that they could face le...
FDA approves updated and revised labeling for Mercks Temodar under the Oncology Center of Excellence Project Renewal pilot program.
FDA issues a safety clarification about its 9/12 Non-prescription Drug Advisory Committees decision that current scientific data do not support the ef...
Zydus Pharmaceuticals asks FDA to ensure that Indocin suppositories and their generics meet ICH guidelines and established impurity acceptance criteri...
Rocket Pharmaceuticals says it has reached an agreement with FDA on a pivotal Phase 2 trial of an investigational gene therapy for Dannon Disease.
Eiger Pharmaceuticals says it is shutting down the Phase 3 LIMT-2 trial of peginterferon lambda in patients with chronic hepatitis delta for safety re...
