To Lower Drug Prices, Look At Generic Industry Health Rather Than FDA, Woodcock Says
US FDA can encourage and increase competition, but cannot force generic companies to enter markets deemed unprofitable, CDER director says.
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Agency will work past generic goal dates if approval can be achieved quickly thereafter, but now must create policy defining criteria for those situations.
FDA's inter-agency drug shortage task force wants comments on whether new shortage prevention and mitigation policies should include closer examination of mergers and acquisitions that could create drug shortages.
OGD Director Uhl says program is now in balance between the number of submissions and agency review actions.