On Biostatistics and Clinical Trials

When trials don’t use a traditional control — What the FDA guidance says In the usual drug-development pathway, regulators expect a trial w...

If new drug application (NDA) or biological license application (BLA) is not approved by the FDA, the sponsor will receive a complete respon...

After the NDA/BLA is submitted to FDA, the FDA review clock starts. There are several critical dates relevant to the applicant (the sponsor)...

This past week, the biotech company BrainStorm announced the decision to submit a BLA to the FDA for NurOwn® (a stem cell treatment) for th...