A two-year pilot will explore the many potential benefits that the analysis of raw data can bring to the EU drug evaluation process. These range from faster patient access to medicines, companies facing fewer questions, and better definition of the target treatment population.
The European Medicines Agency is launching a proof-of-concept pilot to explore whether it can speed up and improve its medicine evaluation process by reviewing individual patient-level data from clinical trials, which is also referred to as raw data.
The pilot is expected to start in September and will run for two years. During this time, companies can volunteer...
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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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the potential consequences for sponsors if enrollment goals are not met, stakeholders say in comments on the DAP draft guidance.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.
