2. FDA simplifies compassion

When all other treatment options have been exhausted, physicians sometimes apply for “expanded access” or “compassionate use” to treat their patients with non-FDA approved pharmaceuticals. The agency recently released a new form for the application, and it’s much shorter and easier to understand than its predecessor. Physicians still need to obtain permission from the drug manufacturer first, but shortening the overall process is the goal. Patients have been eager to speed things up, as evidenced by the 20 states with“right to try” laws, which allow patients to seek post-Phase I experimental therapies without FDA involvement. Who can blame them—red tape has, after all, been linked to adverse health outcomes. Headaches brought on by hours at the DMV count as real-world evidence, right?

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