Gottlieb Added to FasterCures Board

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Former FDA Commissioner Scott Gottlieb has been appointed to the FasterCures advisory board. As a board member, Gottlieb will “leverage decades of experience to provide counsel to the FasterCures team in a variety of areas, including how to best engage patients in research, creating new pathways to innovation through novel financial incentives, and the ways in which a higher-functioning biomedical research system can be advanced,” executive director Tanisha Carino said in an email to FDA Webview.

 

FasterCures, which is part of the Milken Institute, is “working to build a biomedical research and development system that is effective, efficient, and driven by a clear vision: patient needs above all else,” the group says. “Our programs are focused on enabling patients to more easily participate in medical research, creating better pathways to medical innovation, and advancing a high-performing biomedical R&D system. Our network includes top disease foundations, the philanthropic community, financial institutions, and patient advocates.”

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Guide on Biosimilar Postapproval Manufacturing Changes

FDA has released a final guidance entitled “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products — Questions and Answers.” The document explains how manufacturers should document and report changes to approved biosimilars, including changes involving manufacturing processes, production facilities, dosage forms and strengths. Regarding information required for postapproval manufacturing changes,