On April 1, the US FDA is holding a public hearing on the challenges of collecting and analysing information on demographic subgroups, including sex, race, ethnicity and age, in clinical trials for US FDA-regulated medical products.
A recent FDA Voice post from Jonca Bull, Director, FDA’s Office of Minority Health,goes into the necessity to test the safety and effectiveness of medical products in the people they are meant to treat. Although FDA’s policies, guidances, and regulations reflect decades of agency efforts to foster the participation of diverse patient populations in clinical trials, she goes on to say that more work is required.
The US FDA is looking for ideas and viewpoints from stakeholders, ranging from clinical researchers, academia, industry, healthcare professionals and patient advocates, can give their comments, ideas and viewpoints, in person or online, or submit their comments before or after the hearing.
EP News Bureau – Mumbai
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