In 2014, the ASA’s Biopharmaceutical Section started a safety working group (ASA BIOP-SWG) that included members from both regulatory agencies and industry. The working group initially focused on design and analysis of cardiovascular safety outcome trials for type II diabetes drugs. Later, it expanded into a systematic review of multisource safety data and corresponding analysis strategies.
DIA
FDA/DIA Statistics Forum
The FDA/DIA statistics forum will take place April 18–21 in Bethesda, Maryland. The forum provides a venue to discuss important statistical issues associated with the development and review of therapeutic drugs and biologics.