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doi: 10.1074/jbc.M114.571588 42 ShokolenkoIVenediktovaNBochkarevaAWilsonGLAlexeyevMF
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The recurring language is that compounded drugs containing a given substance may pose a risk for immunogenicity for certain routes of administration, and that FDA had identified no or only limited safety information for the proposed routes, so the agency lacked sufficient information to know whether the drug would cause harm
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