Tag:Expanded Use
Pre-Approval Access and Pathways to Investigational Drugs
The Federal Food, Drug, and Cosmetic (FDC) Act of 1938 requires pharmaceutical drugs to provide evidence of their safety before they are allowed on the market. As such, pharmaceutical companies submit applications to the Federal Drug Administration for approval. There are situations, however, in which patients seek to receive access to a particular pharmaceutical drug before the FDA approval process is complete. This blog will explore the various pathways to pre-approval access in addition to recent legislation and legal considerations for such pathways, in addition to the principles and common obstacles that pharmaceutical companies face within such pathways.