Newsletter - March 14, 2019
FDA Pushes for Relaxed Patient Inclusion Criteria for Cancer Trials
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. Read More
Patients Get More Access to FDA Via a New Formal Meeting Requests
Last week FDA launched a new online portal for patients, physicians, patient advocates and support groups. They 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 some major...Read More
FDA Pushes for Relaxed Patient Inclusion Criteria for Cancer Trials
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. Read More
Patients Get More Access to FDA Via a New Formal Meeting Requests
Last week FDA launched a new online portal for patients, physicians, patient advocates and support groups. They 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 some major...Read More
