The WHO is planning to introduce a new version of its tool for evaluating the “maturity level” of national drug regulatory agencies across the world as part of a drive to strengthen regulatory systems and make them more effective and transparent. It is also introducing the concept of "WHO-listed authority".
The World Health Organization plans to adopt its revised system for benchmarking drug regulatory systems early in 2019, with a view to strengthening the capacities of regulatory agencies across the world and bringing them up to new, internationally agreed standards.
The WHO says that doing so will lead to more efficient use of regulatory resources, encourage continuous improvements to regulatory...
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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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the potential consequences for sponsors if enrollment goals are not met, stakeholders say in comments on the DAP draft guidance.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.
