Former FDA associate commissioner Peter Pitts says FDA has an opportunity with the resignation of commissioner Marty Makary to reset its operation and focus on doing things right for patients.
A Clinical Trial Vanguard post describes the issues facing FDA in determining how to review and approve a BLA for a one-time CRISPR gene edit to address a progressive disease.
Former FDA associate commissioner Peter Pitts says FDA has an opportunity with the resignation of commissioner Marty Makary to reset its operation and focus on doing things right for patients.
A Clinical Trial Vanguard post describes the issues facing FDA in determining how to review and approve a BLA for a one-time CRISPR gene edit to address a progressive disease.
FDA warns Alexandria, LA-based cardiologist Naseem Jaffrani about his failure to conduct a clinical investigation according to the investigational plan.
FDA publishes a guidance with recommendations for sponsors planning to submit food-effect studies for INDs or NDAs.
