Fixing accelerated approval

FDA has quietly removed an anomaly in its application of accelerated approval regulations for cancer therapies that had increased uncertainty about the approvals process and potentially discouraged competition to develop breakthrough treatments.

Previously, FDA had interpreted its regulations in a manner that made it difficult for two products to receive accelerated approval for the same indication. Under the old interpretation, a drug was considered an "available" therapy once it received accelerated approval. For another drug to receive accelerated approval for the same indication, the sponsor would have to conduct a randomized trial demonstrating that its product provided a benefit over the available therapy

Read the full 1022 word article

How to gain access

Continue reading with a
two-week free trial.