The afternoon started out with a discussion of Biopharmaceutics Risk Assessment to Guide Dissolution Method Development for Solid Oral Dosage Forms. The presentation provided an introduction to the understanding of the purpose of biopharmaceutics risk assessment and a discussion of how to perform the assessment which focused on understanding the role of in vitro dissolution […]
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. […]
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 […]
Yesterday, the FDA issued a long-awaited guidance titled Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency (here). The guidance notes that the Agency will determine whether remote inspections will occur and which tools are appropriate as alternatives to on-site inspections but indicates that it will not accept […]
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 […]
The FDA notes that many of the emergency use authorization (EUA) tests currently being utilized are subject to false-negative results. The FDA emphasizes (here) that variants seen in the virus may have a significant impact on COVID-19 tests and this will likely occur with greater frequency, especially as some of the variants become predominant in […]
