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August 2011

The FDA plays a “proactive role in promoting innovation,” Commissioner writes

August 2, 2011 -- Despite “common criticisms” that the US Food and Drug Administration (FDA) “impedes innovation by being slow and bureaucratic, we actually play a proactive role in promoting innovation by ushering new products through the approval process and to market—while making sure they meet the standards of safety and effectiveness that have served the American people well,” FDA Commissioner Margaret Hamburg writes in a Wall Street Journal opinion piece. According to Hamburg, the FDA works “quickly and efficiently” when “presented with high-quality applications that are based on strong science.” She adds that the agency must do so, “because our mission is to promote and protect the health of the American people.”

Part of this mission “includes promoting the development of innovative new diagnostics and treatments that will help solve the complex public-health challenges of the 21st century,” Hamburg writes, adding, “This requires working closely with industry, academia, patient and consumer groups, health-care professionals, and others. These include streamlining and improving our approval processes; increasing transparency and building new collaborations; and strengthening the field of regulatory science, at the FDA and beyond.” Hamburg concludes, “President Obama has made it clear that this administration will do everything it takes to promote innovation in medicine and health while preserving the safety and effectiveness of critical medical products. The FDA, working with industry and other groups, is eager to help lead the way.” See the link below for more information.

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