FDA clarifies expanded access process

FDA clarified its expanded access policies in a series of documents issued Thursday, including a Q&A that outlines the process of obtaining expanded access, guidance that describes how companies may charge for therapies given under expanded access programs, and a new form to request access to investigational drugs.

In a statement, FDA Commissioner Robert Califf said the agency hoped to simplify and streamline the process to reduce "procedural burdens on physicians and patients." ...