FDA Spells Out Expanded Access Criteria

The FDA is spelling out the criteria for expanded access to investigational drugs in three final guidances to make the process as clear as possible.

Each of the documents touches on a different facet of the FDA’s compassionate use programs: one is a Q&A on establishing expanded use, another is a Q&A on what charges drugmakers can levy to participants and the third is a document explaining how patients can participate in compassionate use programs.

The finalized Q&A on expanded access has seen the most changes in the three years since the draft version was issued.