US FDA Aims To Speed Communications On Cell And Gene Therapy Issues With Q&A Guidance

Advocates also call for reauthorization negotiations to be open to the public during meeting on the PDUFA VII commitment letter.

FDA Great Room
Will the public be allowed to attend PDUFA VIII negotiations? • Source: Alamy

Sponsors hope that a frequently-asked-questions commitment in the prescription drug user fee reauthorization will speed dissemination of US Food and Drug Administration thinking in the fast-moving cell and gene therapy sector.

As part of the upcoming PDUFA VII renewal, the Center for Biologics Evaluation and Research will publish and regularly update...

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