US FDA Open To Cell Therapy ‘Assessment Aid’ That Could Speed Development Of Next-Gen Cancer Drugs
A framework for sponsors and the FDA to discuss ways to extrapolate existing data to support a new cell therapy could cut the time to approval.
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CBER’s New Home For Gene Therapies: OTAT Changes To OTP But Leadership Questions Remain
US FDA has not named permanent heads of several offices within the new Office of Therapeutic Products, the only super office in the Center for Biologics Evaluation and Research.
US FDA Cell/Gene Therapy Office ‘Aggressively Recruiting’ Amid Reorg, Senior Staff Departures
Transformation of former Office of Tissues and Advanced Therapies into a ‘super office’ will provide leadership opportunities for a younger generation, retiring director Wilson Bryan says. CBER head Peter Marks says he is not concerned if agency staff later go to work for industry; suggests increased staffing and reorg could help cut down on gene therapy IND clinical holds.
US FDA’s Assessment Aid May Spell The End Of Dueling Advisory Committee Briefing Packages
Pilot project allows FDA conclusions about a drug’s efficacy and safety to be integrated with, but distinguished from, a sponsor’s own analysis; though currently used for reviews of oncology applications, template could become the basis for a consolidated advisory committee briefing document.