Sponsors generally should begin pediatric studies after obtaining initial evidence of efficacy and safety from early phase adult trials rather than waiting until initial approval in adults, agency says in a new draft guidance; move toward earlier timeline for pediatric research aligns with recommendations from a 2015 advisory committee, and patient and professional groups.
The US FDA is moving up the timeline for pediatric studies of systemic treatments for atopic dermatitis.
Sponsors should begin pediatric studies "typically after obtaining initial evidence of efficacy and safety from early phase studies in adults"...
US FDA critics have long decried the practice of using informal communications to convey regulatory expectations as podium policy. In the Makary era, the phrase may need to be updated because the agency now seems to be specializing in policy by podcast.
While treatments for scleroderma are in development, none are approved for the condition that is associated with high morbidity and mortality. The European Medicines Agency says guidance on how to design development programs for the disorder is needed.
The FDA will use electronic health records to “get eyes” on drugs immediately after approval, Commissioner Martin Makary told the DIA 2025 Global Annual Meeting. He also wants to reduce development time with better communication and new approval pathways.
The group had been laid off as part of the 1 April reduction-in-force, which led to missed guidance publication deadlines.
While treatments for scleroderma are in development, none are approved for the condition that is associated with high morbidity and mortality. The European Medicines Agency says guidance on how to design development programs for the disorder is needed.
As Chief Medical and Scientific Officer, Vinay Prasad will advise the FDA Commissioner on cross-cutting issues, provide strategic leadership and be a public face of the agency.
US FDA Commissioner Martin Makary will establish "national priorities" used to select sponsors for the pilot of “tumor board-style” drug reviews that would start before Phase III is completed.
