In some cases, the Food and Drug Administration (FDA) will issue postmarketing commitments (PMC) or requirements (PMR) that direct sponsors to collect additional data, through additional clinical trials or other methods, following approval. For instance, the FDA requires drugs approved through the Accelerated Approval pathway to undergo additional postmarket clinical trials in order to confirm safety and efficacy.
Explore our interactive dashboard on PMR/Cs issued to novel oncology drugs.