Wait For Access File

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

If the manufacturer agrees, they must provide an LOA stating they will supply the drug for that specific patient. 4. Physician Responsibilities (Sponsor-Investigator) Wait For Access

The FDA cannot compel a company to provide an unapproved drug; it is a voluntary process for the manufacturer. Identify investigational drugs or devices that have shown

It focuses on moving devices through the premarket review process faster if they demonstrate a breakthrough potential. Once access is granted, the physician is responsible for: Wait For Access

Submitting IND safety reports for any adverse events.

Use databases like ClinicalTrials.gov to find active studies.