FDA delays collecting drugmaker data required by CARES Act

The FDA said this week that it won't begin collecting new data required from drugmakers under the Coronavirus Aid, Relief, and Economic Security Act next month, though the measure is set to take effect Sept. 23, Regulatory Focus reported. 

Though the rule is set to take effect next month, the FDA says the electronic data submission portal it's developing for drugmakers to submit the information won't be ready by then. 

"FDA staff are working to define the data to be reported, create an electronic portal for the submission of this information, and determine when to begin collecting this information. We will provide further updates as our implementation planning continues," the FDA said. 

The CARES Act sets new reporting requirements for drugmakers that are intended to improve the FDA's response to drug shortages. The rules require drugmakers to report shortages of drugs that are critical to public health during a public health emergency as well as the active pharmaceutical ingredients of those drugs. 

Drugmakers are also now required to report manufacturing volume data annually, including the amount of each drug that was manufactured, prepared, propagated, compounded or processed for commercial distribution, according to Regulatory Focus. The rule also gives HHS the discretion to exempt biologics from some or all of the reporting requirements. 

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