FDA Forms Cross-Center Combo Products Council To Resolve Reg Issues

FDA announced the creation of a cross-center policy council Wednesday (April 6) to take the lead on resolving issues associated with regulation of combination products. The move comes as the agency faces pressure from stakeholders and lawmakers to streamline and better coordinate review of combination products. One former FDA commissioner recently suggested the agency develop a separate center to oversee combination products. The agency says its Combination Products Policy Council is based on two other cross center panels -- the...

Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, FDA news and much more.