Wait For Access Site

Identify investigational drugs or devices that have shown promise in clinical trials but are not yet on the market.

There is therapy available to treat the condition. Wait For Access

A physician requesting access for an individual patient takes on the role of a and must handle legal and safety requirements: Identify investigational drugs or devices that have shown

Obtain written informed consent from the patient as per 21 CFR §50.25, ensuring they understand the risks of an unapproved treatment. 5. Expedited Access Programs (Medical Devices) Wait For Access

The FDA cannot compel a company to provide an unapproved drug; it is a voluntary process for the manufacturer.

Before applying for early access, ensure the situation meets core FDA criteria for Expanded Access :