On March 6, 2012, FDA’s Center for Drug Evaluation and Research (CDER) published a Guidance Agenda listing the new and revised draft guidance documents CDER plans to publish during 2012. There are over 50 guidances planned. We will have a busy year reading, understanding and complying with these new and revised guidances. Welcome to the 21st century! Let MWA know how we can assist you with your compliance needs.