According to the FDA: The Life Sciences Industry Relationship with Patients is About to Change – Yea!
The FDA Patient Focused Drug Development meeting held Monday, March 19, 2018 was a game changer for me – and the life sciences industry. The FDA, specifically, the Center for Drug Evaluation and Research (CDER) Office of Strategic Initiatives is responsible for the implementation of the 21st Century Cures Act. This meeting was the second in a series of workshops to implement a four-stage plan to support the Cures Act. At this workshop, the lead, Theresa Mullins, PhD, Associate Director for Strategic Initiatives, made it clear that the goal of the plan is to ensure the patient has input to the full breadth of drug development – from pre-IND through commercial. This is music to my ears! It stunned me that the FDA has evolved to this degree – and it is going to push the industry.