Former cardiology review office director Ellis Unger suggests 70% chance for AA drugs to confirm benefit is an appropriate benchmark, but agency comes nowhere close to withdrawing the remaining 30%.
Accelerated Approval was “a stroke of genius,” when it was created 30 years ago, but the Food & Drug Administration still needs an easier path to removing a product from the market when confirmatory trials fail to show benefit, former FDA review manager Ellis Unger said during a recent Everylife Foundation Congressional caucus briefing.
Unger’s participation during Rare Disease Week marked his first public appearance to discuss FDA regulatory policy since leaving the agency...
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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be implemented.
The agency also should explain the potential consequences for sponsors if enrollment goals are not met, stakeholders say in comments on the DAP draft guidance. Some commenters urged the FDA to apply waiver criteria flexibly, especially for rare diseases.
The US FDA commissioner also said the hub is looking for an executive director who will work with the CBER and CDER heads, who will serve as co-leads.
Brazil has also published its recent regulatory reliance regulations in English, a move designed to increase confidence in its decisions as it presses on with aligning its national practices with global best practices.
The US FDA commissioner also said the hub is looking for an executive director who will work with the CBER and CDER heads, who will serve as co-leads.
The FDA and sponsors of two new accelerated approval drugs for PBC have taken steps in study design, initiation and reporting transparency to ensure timely completion; Intercept’s COBALT trial of obeticholic acid was negatively impacted by product safety labeling changes and a high crossover rate to commercial drug.
