Drug Shortage Rules Surface In Latest FDA Regulatory Agenda
FDA has yet to prognosticate on a schedule for other FDASIA-mandated regulations; HHS says that FDA’s priorities for the coming year will involve devices and food, as well as promoting international regulatory cooperation.
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In legislation passed by both chambers of Congress Jan. 1, the cost of a one-year reprieve from sharp cuts to Medicare physician payments, scheduled to begin in 2013, would be offset by a reduction in Medicare’s bundled payment for end-stage renal disease. The reduced payment would take into account a drop in the use of erythropoiesis-stimulating agents observed over the last several years.
The agency has the option to issue regulations requiring biologics manufacturers to notify FDA of emerging production problems, but so far it’s only “something that we’re thinking about.”
Institute of Medicine report recommends how FDA, industry and other stakeholders can strengthen food and drug regulatory systems abroad. It calls for FDA to provide incentives for foreign regulators to meet U.S. standards and facilitate training and for the government to help hold importers liable.