Updates on the Guidances for Industry: Integrated Summaries of Effectiveness and Safety
View Presentation View Presentation
*Howard D. Chazin, FDA/CDER/OND 


The speaker is one of co-authors of the ISE & ISS guidances. He will give a15-minute presentation; focusing on the updates on the content and objectives of the ISE and ISS guidance from the regulatory perspective. He will also participate in the panel composed of FDA and industry statisticians and clinicians exchanging views and Q/A with audience.