Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
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Shire’s Motegrity: US FDA Panel Nod On CV Safety Comes With Concern About Neuropsych Events
In unanimously endorsing prucalopride for chronic idiopathic constipation, advisory committee seems reassured by extensive data on 5-HT4 agonist’s cardiovascular safety, but some members called for an epidemiological study to assess possible suicidality signal.
Zelnorm's Return: US FDA Panel Hands Down Split Decision On Constipation Drug's Target Population
Seven advisory committee members said the treatment for irritable bowel syndrome with constipation should be labeled for females at low cardiovascular risk; three panelists, including two cardiologists, supported a narrower indication limited to low CV risk patients who also suffer from severe symptoms.
US FDA May Change Requirements For CV Outcomes Trials For Type 2 Diabetes Drugs
Endocrinologic and Metabolic Drugs Advisory Committee will reconsider 2008 guidance on evaluating CV risks in antidiabetic therapies at two-day meeting in October.