HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, […]
FDA has released several FRNs over the past few years covering the PQ/CMC project. As new sections of Module 3 eCTD (Electronic Common Technical Document) are […]
About 7% of US adults report having or having had symptoms of long COVID such as fatigue, heart palpitations and/or dizziness. These are three of the […]
UPDATE (Jan. 8, 2024): FDA is aware that some providers, including hospital or health-system pharmacies, may be preparing other STS products for patient use in place of […]
“Q&A with FDA” provides engaging conversation and discussion about the latest regulatory topics. In this podcast series, FDA’s Division of Drug Information will answer some of […]
New data continued to show clinical benefits from continuous glucose monitoring (CGM) in people with type 2 diabetes, including those who don’t use insulin. Use of […]
Skipping meals, mood and anxiety disorders, as well as vaping and substance use, all raise the risk for frequent recurrent headaches in children and adolescents, new […]
San Diego — In separate studies evaluating treatments for severe forms of alopecia, inhibitors of Janus kinases (JAKs) produced clinically meaningful hair regrowth, according to late-breaking […]
The National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending that patients being treated for visual impairment caused by chronic diabetic […]
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