US FDA approved expanded label for male breast cancer based on a supplement that included only non-traditional data sets. But agency is making clear that the “substantial” evidence for efficacy still came from the traditional pivotal trials – in women.
The US Food & Drug Administration’s recent approval of Pfizer Inc.’s Ibrancefor use in male breast cancer is a milestone of sorts for applying real-world data to regulatory decisions: the supplemental NDA was entirely composed of non-traditional “real-world” datasets.
FDA approved the Ibrancesupplement on April 4, and Pfizer announced at the time that the application was based...
Exploring How Everyday Industrial Compounds Enter Our Systems, Their Health Implications, and the Ongoing Quest for Safer Alternatives .
With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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the potential consequences for sponsors if enrollment goals are not met, stakeholders say in comments on the DAP draft guidance.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.
