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Biopharmaceuticals generic drug products

CDER has a larger product development responsibility than CBER, and thus has five Therapeutic Review Divisions, each led by a career civil servant Division Director. But the other divisions are similar to the CBER model, with divisions for Epidemiology and Statistics, Compliance, Pharmaceutical Sciences (including a specialized office of New Drug Chemistry), Biopharmaceutics and Generic Drugs. It seems likely that an Office for Toxicology will soon be established. [Pg.401]

Most importantly, for biopharmaceuticals, however, and the eventual entry of generic products of biotechnological research into the marketplace (see discussion below) is the Restoration Act or Hatch-Waxman Amendments to the Drug Price Competition and Patent Term Restoration Act of 1984 [106]. This act creates an... [Pg.1418]


See other pages where Biopharmaceuticals generic drug products is mentioned: [Pg.821]    [Pg.186]    [Pg.94]    [Pg.9]    [Pg.380]    [Pg.112]    [Pg.524]    [Pg.1783]    [Pg.38]    [Pg.362]    [Pg.10]    [Pg.27]    [Pg.9]    [Pg.14]    [Pg.161]    [Pg.246]    [Pg.174]    [Pg.192]    [Pg.367]    [Pg.68]    [Pg.43]    [Pg.385]    [Pg.1713]    [Pg.1729]    [Pg.1731]    [Pg.1758]    [Pg.1833]    [Pg.362]    [Pg.219]   
See also in sourсe #XX -- [ Pg.97 ]




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Generic drug

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