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Janssen Pharmaceuticals Inc.

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Latest From Janssen Pharmaceuticals Inc.

The Evolving Door? What Having A ‘Big Data’ Commissioner Might Mean For US FDA

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.

FDA Leadership

Janssen’s Sarich: Randomized Controlled Trials, Real-World Evidence Go Best Together

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.

Research & Development Artificial Intelligence

AAV Vector Consortia Address Quality Assays, Endpoints

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

Gene Therapy Drug Approval Standards

Keeping Track: Parsaclisib, Kymriah Applications Target Non-Hodgkin Lymphomas; AbbVie Gets New Use For Old Ophthalmic

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

US FDA Performance Tracker Approvals
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