Accutane Pregnancy Exposure May Have Increased Under Risk Management Plan, FDA Says
This article was originally published in The Pink Sheet Daily
During the first year of the SMART program, there were 120 pregnancy exposures, compared to 127 in the year prior to implementation of Roche's enhanced risk management program. The 23% decrease in prescriptions for the severe acne treatment suggests a relative increase in exposure.
You may also be interested in...
FDA advisory committee suggests enhancements to Roche's SMART program to better prevent pregnancies. The proposal calls for a shared brand/generic system for patient registration.
Deal Snapshot: The firms are partnering on a digital therapeutic for schizophrenia in a deal potentially worth $500m.