Robert Califf’s nomination to return as FDA commissioner will raise protests about a ‘revolving door’ pathway between industry and agency. But, in this case, it may be more apt to talk about how Califf’s time outside FDA led to evolving views on the role of big data in drug regulation.

Janssen’s Troy Sarich outlines why it’s hard to emulate randomized controlled trials with real-world evidence studies, emphasizing that the two are “not in competition.” He also highlights the huge strides made by AI-driven technology firms to provide “research-ready” structured data and new game-changing advances in the area of health sensors.

Two outside groups aim to help CBER on gene therapy questions from ‘N of one’ to markers for hemophilia.

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker