Importation policies on sole source medicines

By Dr Nicola Davies

Safeguarding patient access to critical medicines is a key responsibility of the US Food and Drug Administration. To continually fulfill this responsibility, the agency has recently created a working group tasked with developing a policy framework for the importation of foreign versions of sole source medicines. Sole source medicines are FDA-approved and marketed products in the US that are manufactured by only one company, writes Dr Nicola Davies in a regular FDA blog for The Pharma Letter.

Patient access to sole source medicines