FDA Holds Off Manufacturing Volume Collecting Data under CARES Act

August 26, 2020

The FDA has said it will not begin collecting manufacturing volume data from drugmakers by Sept. 23 as required under the Coronavirus Aid, Relief, and Economic Security (CARES) Act.

The agency said the electronic submission portal will not be ready in time, adding that it still needs to decide which data should be reported and when it will start the collection.  

Signed into law in March, the CARES Act requires drugmakers to report how much of their drugs were manufactured or prepared for commercial distribution to help the FDA identify potential shortages.

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