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Imprese · 13/02/20181 min di lettura
Bacillus Calmette-Guérin-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment; Guidance for Industry; Availability
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Riepilogo
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled "Bacillus Calmette-Gu[eacute]rin (BCG)-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment." This guidance was developed to assist in the development of drugs and biologics for patients with a form of bladder cancer that is not amenable to currently available medical therapy and remains an unmet medical need. This guidance finalizes the draft guidance of the same name issued on November 18, 2016.
Lingua originale della fonte: Federal Register — Food and Drug AdministrationApri il comunicato originale →