The afternoon sessions of FDA’s Generic Drug Forum on April 28, 2021 were very information-intense and provided a significant amount of review information and suggestions for success in ANDA submission and approval. Caliope Sarago, Senior Regulatory Health Project Manager, Office of Research and Standards, Office of Generic Drugs, gave a comprehensive review of the pre-ANDA […]
There were numerous presenters in the morning session on April 28, 2021. Below are some of the highlights. Dr. Sally Choe, Director, Office of Generic Drugs (OGD) noted that OGD has prioritized assessment of over 50 ANDAs and more than 800 supplemental applications in FY 2021 to meet the needs associated with the Covid-19 pandemic. […]
An article in STAT (here) (paid subscription required), authored by a former FDAer, Jane Axelrad, should be read by all in the pharmaceutical industry. Axelrad notes that, while online access to current prescribing information has been available for over fifteen years, progress in eliminating the requirement to provide paper labels has been stymied by paper […]
The FDA released its Activities Report of the Generic Drugs Program | GDUFA II Quarterly Performance for the second quarter of FY 2021 late yesterday. And there were not any real surprises. Y2021 First Quarter October – December Second Quarter January – March Third Quarter April – June Fourth quarter July – September ANDAs awaiting […]
As the OGD has reported the official approval numbers for March, let us note that we projected the actual number (63) in our unofficial count (here) in our April 5th post. Please realize that this month (March) included a number of reports of approval actions for multiple strengths within a single ANDA, reflecting a change […]
With 11 reporting days into April, and 11 more to go, OGD has issued 25 full approval actions and 11 tentative approval actions for a total of 36 approval actions. One application for VILAZODONE HYDROCHLORIDE was responsible for two actions (1 full approval and 1 tentative approval), as only one of its strengths was eligible […]
OGD updated and provided the remainder of its monthly metrics for February 2021 in its Generic Drugs Program Activities Report – Monthly Performance (here). Here are some interesting observations! OGD issued 7 refuse-to-receive (RTR) actions which is the most since January 2020 when they also issued 7 RTR actions. All were for standard ANDA applications. […]
Okay, so you want to bring a product back from the dead. That is, you want to file an ANDA for an older discontinued product without competition and with no designated reference listed drug (RLD) or reference standard (RS) published in the Orange Book (OB). Oh yeah, and you also want to start a development […]
We previously intimated (here) that March came in like a lion but might go out like a lamb; however, thanks to a flurry of approval actions in the last four days of the month, it looks like the lion might have stayed in the approval picture for most of the month. The unofficial number of […]
Well, a little late this month, but OGD posted the first wave of its February 2021 metrics. The Agency issued 72 Approval actions and 7 tentative approval actions (we reported 72 and 6 respectively (here -looks like they snuck in a late TA). So, a total of 79 total approval actions in February, which just […]
