Citeline Regulatory reposted this
💠New US FDA Adcomm Trend: Approved Cancer Meds Get Another Look When Competitors Coming • Who should read this? Oncology sponsors and any regulatory affairs professionals who may deal with US FDA advisory committees. • What is it about? The Pink Sheet has spotted a trend of the FDA expanding its focus beyond cancer applications with pending approval decisions to refining trial designs and drug labels for competitors. • Why is it important? These unusual meetings may become more common, as they are consistent with Commissioner Robert Califf's vision for advisory committee reform. Sponsors may need to anticipate that a competitor product's pending approval could call them back to an advisory committee meeting for labeling refinement. Citeline Citeline Commercial Citeline Regulatory #FDA #oncology