Early Access Care is the solution to pharmaceutical company compliance with the new legislation as it pertains to Expanded Access.
Our leadership has provided expertise and policy development guidance to the Brookings Institute for Health Policy, FDA, and small and large biopharmaceutical companies.
We have been sharing our expertise with biopharmaceutical companies for many years through symposia and publications. Our leadership contributed to the Brooking's Health Policy Issue Brief "The Four A's of Expanding Patient Access to Life-Saving Treatments and the Regulatory Implications". This reference provides a key source of information of considerations in the establishment of a pre-approval policy relevant to any sized biopharmaceutical company.