Agency discourages use of externally controlled trials in all but a very limited number of situations truly ripe for such an approach; new draft guidance discusses at length the various confounding factors that can introduce bias into a comparison between an investigational treatment and an external control using either real-world data or data from another clinical trial.
The US Food and Drug Administration’s draft guidance on design and conduct of externally controlled trials may give sponsors more clarity on use of such approaches, but considerable obstacles remain to demonstrating drug efficacy or safety to the agency’s satisfaction.
Through the guidance, the FDA seeks to discourage use of externally controlled trials in all but a very limited...
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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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the potential consequences for sponsors if enrollment goals are not met, stakeholders say in comments on the DAP draft guidance.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.
