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The House passed a bill last week that would put an 18-month moratorium on the device branding provision in the Medical Device User Fee and Modernization Act (MDUFAMA).
The FDA has been asked by a high-ranking House Democrat to explain why the enforcement of regulations barring false and misleading drug advertisements has declined, despite promises from agency Commissioner Mark McClellan that actions would increase.
The FDA approved 25 new biotechnology drugs and biologics in 2003, up 25 percent from the year before, the Biotechnology Industry Organization (BIO) said yesterday.
HHS Secretary Tommy Thompson should use the department’s federal negotiating power to lower the costs of drugs under Medicare, according to a bipartisan group of 16 senators.