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Posted 17 October 2013 | By Alexander Gaffney, RAC,
The US federal government may have been shut down, but that didn't stop the US Food and Drug Administration (FDA) from releasing a new guidance document on 16 October 2013 detailing its preferred methods of developing applications in support of drugs to treat chronic infections caused by the hepatitis C virus.
FDA has been rather active in the hepatitis C drug development space in recent years. In 2009, it issued a final guidance document, Guidance on Antiviral Product Development-Conducting and Submitting Virology Studies, which was intended to assist in the development of new antivirals by establishing the data which are essential to submitting a successful regulatory application.
In February 2013, FDA released a document known as a guidance "attachment"-a short, three-page basic outline explaining how data submitted to the agency should be formatted.
In its latest guidance, Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment, FDA seeks to promote clarity for developers of direct-acting antiviral (DAA) drugs. Such drugs are defined as those that disrupt the replication cycle of the virus directly (i.e. not indirectly, such as immune-system boosting products).
The last iteration of the guidance was published in September 2010, but regulators observed that the rapid development of therapies in the space necessitated further clarification. FDA notes that significant changes to the current guidance include:
Due to ongoing advancements-there are "substantial scientific advancements announced at every major liver disease meeting," according to FDA-regulators also advised sponsors to reach out to FDA's Division of Antiviral Products (DAVP) during the pre-investigational new drug consultation (pre-IND) stage regarding scientific advancements that affect their respective drug development programs.
The draft guidance has not yet been published in the Federal Register, but industry will likely have 60-90 days in which to comment when it is eventually published.
Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment
Tags: Hepatitis C, draft guidance, guidance, virus
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