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Home » FDA May Fear Setting Precedent For PHS Act Biogeneric Approvals
FDA May Fear Setting Precedent For PHS Act Biogeneric Approvals
November 29, 2005
The FDA is not approving some 505(b)(2) drug applications for products such as Sandoz's human growth hormone Omnitrope because the agency is concerned such a move would set a precedent for approving biological products under Section 351 of the Public Health Service (PHS) Act, according to one industry observer.