Well, I am back from three weeks of traipsing around South America and ready to hit the blogging trail again. Thanks to all my Lachman colleagues who took up the charge and did a great job in my absence. However, while away, I tried to keep up by reading the trade press when I had access to the internet,
The Office of Generic Drugs (OGD) updated its December 2019 (first quarter FY 2020) statistics with metrics, in addition to the approvals, receipts of original ANDAs, and complete response letters that were published a few weeks ago.
The OGD reported refusing-to-receive (RTR) four ANDAs, three standard review and one priority review application. While four is the highest number of RTRs issued this FY (the first two months had one and three),