Generic Sample Access Process For REMS-Protected Brands Now Includes Agency Timeline

The US Food and Drug Administration process to issue letters helping generic sponsors obtain samples of products covered by a Risk Evaluation and Mitigation Strategy is being tweaked as interest in the program remains strong.

Since the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act was enacted in December 2019, the agency has issued 60 Covered Product Authorizations (CPAs) and denied only two....