FDA says volume manufacturing deadline is not a requirement after drugmakers lash out
Back in October, the FDA released a controversial draft guidance explaining to drug manufacturers how, beginning on Feb. 15, 2022, the FDA would start collecting annual manufacturing reports.
It would start with 2020 manufacturing data, including the volume or amount of each drug, and the same for active pharmaceutical ingredients.
The reports were created as part of the CARES Act, enacted in May 2020, which aided the Covid-19 response funding and added new provisions, like this one, meant to address pandemic-exacerbated drug shortages, by improving FDA’s visibility into drug/API supply chains.
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