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

US FDA has 120 days to review generic sponsors’ requests for letters to help them obtain product samples, but will not send them to the reference product company.

writting a letter — FDA has issued 60 Covered Product Authorization letters • Source: Shutterstock

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...