Was Coronavirus A Factor In US FDA Approval Of Proventil HFA First Generic?
Executive Summary
The agency said Cipla’s ANDA met all the requirements for approval, but also that there is increased demand for the products.
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Generic drugs program has approved almost 300 manufacturing changes to help shore up the supply chain, with some prior approval supplements being downgraded to ‘changes being effected’ supplements, FDA officials said at GDUFA III kick-off meeting.
US FDA Expediting ANDA Postapproval Manufacturing Changes Due To COVID-19 Impacts
Generic drugs program has approved almost 300 manufacturing changes to help shore up the supply chain, with some prior approval supplements being downgraded to ‘changes being effected’ supplements, FDA officials said at GDUFA III kick-off meeting.