FDA Rejects Petition for Review of Gene Therapy Product for Safety Concerns Involving Vulnerable Patient Population

Is the filing of a citizen petition with the U.S. Food and Drug Administration (FDA) an appropriate action for requesting review of a Biological License Application (BLA) if there are safety concerns in a particular gene therapy involving vulnerable patients? Apparently not, according to a letter from Peter Marks, Director of the agency’s Center for Biologics Evaluation and Research Director to Patrick Girondi, founder, and Chief Executive Officer of San Rocco Therapeutics LLC (SRT).

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