June 13 PIV List – A Bend in the River?
Once or twice a month, FDA issues a PIV List providing information for newly-filed, first-filed ANDAs. The June 13 List was rather remarkable – it contained 9 products, 8 of which represented ANDAs filed in April. This PIV activity has not been seen since 2014. Does the June 13 FDA List mark a turn in … Continue reading →