FDA publishes a guidance on clinical pharmacology studies to support biosimilar product applications.
The CDER Office of Prescription Drug Promotion says that Zydus Discovery DMCC is using a YouTube video to promote its Lipaglyn, which is an investigat...
FDA Review posts Warning Letter summaries for letters released during our holiday break (12/19 to 12/30).
FDA Webview posts the Federal Register summaries for notices released during our holiday break (12/19 to 12/30).
FDA says it is reducing the time it takes to post medical device recall information in its medical device recalls database.
FDA warns Indias Wockhardt Limited about CGMP violations and deviations in its production of finished pharmaceuticals and active pharmaceutical ingred...
CDERs Office of Prescription Drug Promotion says that Chiasma is promoting its investigational new drug octreotide in a YouTube video.
Federal Register Notice: FDA releases a draft guidance on Premarket Notification (510(k)) Submissions for Bone Anchors.