CDER Conversations
Interviews with CDER experts on priorities, projects, and initiatives
Software Associated with Prescription Drugs: Opportunities to Enhance Safe and Effective Medication Use
FDA has released a draft guidance, “Regulatory Considerations for Prescription Drug-Use-Related Software,” to share the agency’s current thinking on software that accompanies or supplements prescription drugs.
In this CDER Conversation, the Office of Medical Policy’s Evan Wearne, PharmD, MS, explains the role that software may play in promoting safe and effective drug use, the intent of the guidance, and the future interplay between software and therapeutics.