Search Results for Antiviral

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FDA Finalizes Guidance on Antiviral Drugs for Cold Sores By Michael Mezher - Published 07 November 2017

The US Food and Drug Administration (FDA) on Tuesday finalized guidance on developing antiviral drugs for recurrent herpes labialis (RHL), commonly referred to as cold sores, which affects between 20% and 40% of adults in the US.

Categories: News, US, FDA, Clinical, Drugs, Preclinical

Tags: Antiviral, Recurrent Herpes Labialis, RHL, Cold Sores

NGS Altering the Landscape of Antiviral Drug Resistance Analysis, FDA Officials Say By Zachary Brennan - Published 20 November 2015

As next-generation sequencing (NGS) costs gradually decline, the Food and Drug Administration’s (FDA) Division of Antiviral Products (DAVP) anticipates that more companies will make the switch to NGS for future antiviral drug resistance analyses and other additional uses.

Categories: News, US, FDA, Biologics and biotechnology, Compliance, Drugs, Due Diligence, Quality, Regulatory intelligence, Regulatory strategy

Tags: next-generation sequencing, NGS, FDA, HIV drugs, antiviral drugs, gene sequencing

FDA Gives New Name, Authority to One of its Advisory Committees By Alexander Gaffney, RAC - Published 03 April 2015

The US Food and Drug Administration (FDA) has formally announced it will rename its Anti-Infective Drugs Advisory Committee (AIDAC), just weeks after announcing the committee would now oversee all HIV and AIDS drugs.

Categories: News, US, CDER, Biologics and biotechnology, Drugs

Tags: Advisory Committee, Antimicrobial Drugs Advisory Committee, Antiviral Drugs Advisory Committee

Updated: FDA Disbands Advisory Committee in Charge of Review of HIV, AIDS Drugs By Alexander Gaffney, RAC - Published 20 March 2015

The US Food and Drug Administration (FDA) has disbanded its Antiviral Drugs Advisory Committee, a committee charged with the review of products intended to treat HIV and AIDS, the agency announced this week.

Categories: News, US, FDA, Drugs

Tags: HIV, AIDS, Advisory Committee, AdComm, Antiviral Drugs Advisory Committee, Anti-viral Drugs Advisory Committee