The FDA has been working to improve the process used by physicians to request Expanded Access — Compassionate Use to investigational drugs and biologics for their patients who need these therapies to stay alive. In a statement released in early June from FDA Commissioner Robert Califf, M. D., the FDA released 3 guidance documents with information on Compassionate Use drugs and biologics.
The first guidance to note covers Individual Patient Expanded Access Applications – Form FDA 3926. New Form 3926 is specifically for physicians to use to request access to investigational drugs for their patients who need these therapies to stay alive. FDA also has instructions for completing the form.
There are 2 additional guidance documents to note that provide additional clarity on Compassionate Use. One of the guidance documents explains Compassionate Use using a Question and Answer format – click here to read. The other guidance covers how a patient may be charged for these investigational drugs – click here to read.
Pearl Pathways’ and Pearl IRB’s experienced teams are ready to help you with this process. Expediting regulatory pathways is what we are about — contact us.