Four House Democrats and Republicans urge FDA to take a greater role in protecting U.S. national security interests that could be at risk when drug co...
FDA warns Indias Eugia Pharma Specialties about CGMP violations in its production of finished drugs.
The Association for Molecular Pathology and a pathologist sue FDA to block implementation of the agencys final rule asserting regulatory authority ove...
Eli Lilly says data from its SURMOUNT-1 study showed that tirzepatide contributed to significant weight loss and delayed in progression to diabetes in...
A Hyman, Phelps & McNamara medical device regulatory expert and attorney say FDA needs to improve the timeliness of its posting of de novo decision su...
ICU Medical expands a Class 1 recall of its Plum 360, Plum A+ and Plum A+3 Infusion Systems to update the use instructions due to a manufacturing defe...
FDA grants ReAlta Life Sciences orphan drug and fast track designations for RLS-0071 and its use in treating hospitalized patients with steroid-refrac...
FDA posts a final guidance entitled Product-Specific Guidance (PSG) Meetings Between FDA and ANDA Applicants Under GDUFA.
