FDA delays collecting drugmaker data required by CARES Act

The FDA stated today that it wont start gathering new information required from drugmakers under the Coronavirus Aid, Relief, and Economic Security Act next month, though the measure is set to work Sept. 23, Regulatory Focus reported..

” FDA staff are working to define the information to be reported, produce an electronic website for the submission of this details, and determine when to begin collecting this details. We will provide additional updates as our application planning continues,” the FDA said..

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The CARES Act sets new reporting requirements for drugmakers that are intended to improve the FDAs response to drug shortages. The guidelines need drugmakers to report shortages of drugs that are important to public health throughout a public health emergency as well as the active pharmaceutical ingredients of those drugs..

Though the rule is set to work next month, the FDA states the electronic information submission portal its establishing for drugmakers to send the information will not be ready by then..

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Drugmakers are also now required to report making volume data annually, consisting of the quantity of each drug that was produced, prepared, propagated, intensified or processed for industrial circulation, according to Regulatory Focus. The guideline likewise gives HHS the discretion to exempt biologics from some or all of the reporting requirements..

Maia Anderson –
Wednesday, August 26th, 2020
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