A proposed change in federal regulations would make it possible for universities and biotech companies to make drugs in their own labs for Phase I trials. Under existing rules, universities and biotechs often have to outsource the manufacture of Phase I drugs to specialty manufacturers. That can be prohibitively expensive for small research budgets and a new standard would lower drug development costs. If the rules are relaxed, though, some critics say that the FDA may be opening the door to increasing the safety risks of the volunteers in early-stage trials.
- check out the Triangle Business Journal report on the proposed rule change