FDA proposes changes in access and charges for experimental drugsBMJ 2007; 334 doi: https://doi.org/10.1136/bmj.39084.415162.DE (Published 04 January 2007) Cite this as: BMJ 2007;334:12
- Bob Roehr
- 1Washington, DC
The US Food and Drug Administration (FDA) has proposed new rules that would make experimental drugs for serious or life threatening diseases more widely available to patients who lack other therapeutic options. The draft regulations were issued on 11 December and public comments will be accepted for 90 days.
Currently, access to experimental drugs has varied, depending on the disease and the section of the FDA with oversight of that pharmaceutical product. The proposed rules would clarify and standardise that process, explained Richard Klein of the FDA's office of special …