Efficient development and review is being hindered by the inability to exchange data freely and truly capitalize on the digital age, CDER director says, challenging industry, regulators and others to creatively think about how to move away from legacy, paper-based processes in clinical trials and regulatory submissions.
The US FDA’s Janet Woodcock is issuing a call to action to better leverage technology in drug development and regulatory review, starting with the elimination of “digitized paper.”
Speaking at the Friends of Cancer Research (FOCR) annual meeting in Washington, DC Nov