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FDA Would Ease AER Requirements During Flu Pandemic

This article was originally published in The Tan Sheet

Executive Summary

FDA would suspend some mandatory adverse event reports for drug and dietary supplement manufacturers temporarily during a widespread flu pandemic, according to a draft guidance

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In Brief

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Roche’s Flu MedKit Seeks “Alternate Pathway” For OTC Drugs

The antiviral drug home stockpiling MedKit being shepherded by the Department of Health and Human Services could be the first product to test FDA's stated interest in "creative paths to access" that straddle or depart from the traditional choice of Rx or OTC status

FDA Panel To Influenza Home MedKit Sponsors: Get Real

Roche begins label comprehension studies this month to support development of aTamiflu home MedKit for the treatment or prophylaxis of pandemic influenza virus, under an initiative driven by the Department of Health and Human Services

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