Comment from Mitchell Berger
AnonymousSupportIndividual
Summary: Mitchell Berger, submitting in a personal capacity, suggests that the FDA include a pediatric track, discuss the use of real-world data for post-market monitoring, and involve more diverse stakeholders like other government agencies and patient panels in the workshop. He argues that these additions would improve collaboration and address specific needs such as pediatric drug shortages and off-label use.
Dear Drs. Lionberger and Raney: In response to the above Federal Register notice concerning the Generic Drug Science and Research Initiatives workshop I have the following suggestions: Consider having a pediatric track at the upcoming workshop or focusing some topics or discussions specifically on pediatric populations; Discuss use of real-world data for post-market monitoring of generic drugs; and Include discussants and presenters from other government agencies and a consumer/patient panel or perspective to bolster collaboration and coordination. Thank you for your consideration of this input, which reflects solely my personal views. Full comment attached. Sincerely, Mitchell Berger