Day: March 14, 2019

Last week FDA launched a new online portal for patients, physicians, patient advocates and support groups can formally and directly request meetings with the FDA to discuss their disease and ask about specific FDA regulated products. Over the last few years, patients have been able to interact with FDA directly and that has led to … Read more

The clinical trial recruitment criteria must be modernized to accurately reflect measures needed for the safety of the participants, and to diligently evaluate the investigational product. This week FDA published five new Guidance Documents to rebut common exclusion criteria used for all clinical trials, specifically trials in cancer patients. The goal is to eliminate common … Read more