Expediting Expanded Access

The FDA clarified its expanded access policies in a series of documents including a Q and 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.
FDA Commissioner Robert Califf said the agency hoped to simplify and streamline the process to reduce "procedural burdens on physicians and patients."
Source: drugwonks.com Blog - Category: Pharmaceuticals Source Type: blogs