Arnall Golden Gregory partner Alan Minsk predicts that CDER Office of Prescription Drug Promotion staff this year are likely to focus on materials dis...
FDA officials on a bioresearch monitoring Webinar offer good clinical practice recommendations to sponsors and clinical trial site operators to avoid ...
FDA sends a letter to healthcare professionals that emphasizes the importance of lifelong surveillance of patients with abdominal aortic aneurysm endo...
FDA extends by three months its review of an AbbVie supplemental BLA for Skyrizi (risankizumab-rzaa) for treating moderate to severe Crohns disease.
FDA Review posts the Federal Register notices for the week ending 2/25/2022.
FDA Review posts product approval summaries for the week ending 2/25/2022.
FDA revises an AstraZeneca emergency use authorization for Evusheld (tixagevimab co-packaged with cilgavimab) to increase the initial dose for Covid-1...