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12:00 AM
Sep 06, 2004
 |  BioCentury  |  Politics, Policy & Law

FDA blinks

FDA has effectively blocked a pathway that was widely expected, both within the agency and in industry, to provide opportunities to market follow-on versions of proteins that are regulated as drugs. By deferring a decision on approval of Sandoz's Omnitrope human growth hormone (hGH), the agency handed a victory to that portion of the industry that has been fighting to block approval of follow-on biologics (FOBs) and probably put the issue on track to be addressed by Congress.

Last week's decision ran counter to the statements of a number of agency officials, including former Commissioner Mark McClellan, that FDA has the legal authority to use section 505(b)(2) of the Food, Drug and Cosmetic Act to approve applications for hGH or insulin...

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