The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment.'' The purpose of this guidance is to assist sponsors in all phases of development of direct-acting antiviral (DAA) drugs for the treatment of chronic hepatitis C. This guidance finalizes the draft guidance of the same name issued on May 4, 2016.
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Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Chronic Hepatitis C Virus Infection: Developing Direct-Acti...
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82 FR 51636
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“Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment; Guidance for Industry; Availability,” thefederalregister.org (November 7, 2017), https://thefederalregister.org/documents/2017-24195/chronic-hepatitis-c-virus-infection-developing-direct-acting-antiviral-drugs-for-treatment-guidance-for-industry-availab.