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Pharmaceuticals post-approval changes

Recently the FDA, with the cooperation of the Pharmaceutical Industry has developed a series of guidance procedures to speed approval of post approval changes with or without process scale-up changes. At the present time the SUPAC (scale-up post approval change) program covers the following product categories ... [Pg.3936]

See other pages where Pharmaceuticals post-approval changes is mentioned: [Pg.84]    [Pg.323]    [Pg.539]    [Pg.72]    [Pg.244]    [Pg.352]    [Pg.415]    [Pg.499]    [Pg.23]    [Pg.798]    [Pg.326]    [Pg.5]    [Pg.5]    [Pg.392]    [Pg.522]    [Pg.586]    [Pg.326]    [Pg.428]    [Pg.111]    [Pg.112]    [Pg.4]    [Pg.33]    [Pg.367]    [Pg.314]    [Pg.337]    [Pg.600]   
See also in sourсe #XX -- [ Pg.36 ]



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Post-approval changes

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