How many times have you had a question about the listings in the Orange Book (OB) but were not sure who to ask? Well, a lot of people have obviously stood in your shoes, as this draft guidance titled Orange Book Questions and Answers Guidance for Industry (here) publishes a great Q&A from those who […]
The FDA released a guidance to remain in effect until the COVID-19 public health emergency is resolved titled Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications — Questions and Answers ( here). In this guidance, the Agency addresses many questions they have been asked about scheduling meetings, face-to-face (FTF) […]
Sports fans, are you deprived of watching real time live sporting events? The German teams have started up in the Bundesliga again. But I have a better idea! How about watching the race to approvals that the Office of Generic Drugs is running? Posting their approval action for April today shows that they are running […]
The Office of Generic Drugs updated its March 2020 statistics today (here) with few surprises. As they say on American Idol, when giving the results, “dim the lights and here we go.” The OGD again refused to receive only three ANDAs in March and all three were for standard review ANDAs. There were sixty-three ANDAs […]
Based on the FDA All Approval List (here, search for April), it appears that the Office of Generic Drugs had a banner month with 65 full approval actions and 22 tentative approval actions, for a total of 85 approval actions for the month. Of course, these are preliminary numbers, as OGD will not likely publish […]
Through April 19 (and one action for the 20th) reporting on the FDA all Approvals list (here) tallies 37 full approval actions and 16 tentative approval actions for a total of 53 approval actions. The month started out very strong and, if the rate of approvals continues through the end of the month, OGD might […]
FDA released Revision 1 to its November 12, 2015 Manual of Policy and Procedures (MAPP) 5200.7 which contains “minor clarifications and formatting”, and added Attachment 2 – Work Guide for Prior Approval Supplements: Requirements for a Filing Review. Just a reminder that a MAPP is a document that provides a transparent view into how the […]
The FDA posted a notice indicating that they continue “to investigate the presence of the N-Nitrosodimethylamine (NDMA) impurity in ranitidine and is now aware of NDMA in nizatidine, which is chemically similar to ranitidine.“ They have found levels on NDMA in one company’s product that exceed the accepted limits and that company has initiated recall […]
Yesterday was day one of the 2-day Generic Drug Forum presented virtually by the Agency in conjunction with the CDER Small Business and Industry Assistance program. There were many sessions which are all available here, including presentations on product-specific guidances, OGD labeling review and requirements, new program requirements under FDARA, pre-ANDA interactions with FDA, electronic […]
Today OGD provided partial information for the typical first reported March Metrics and updated its February 2020 metrics. Let’s start with the new March data. OGD reports 60 full approval actions and 17 tentative approval actions for a total of 77 approval actions for original applications in March, which is the highest number of total […]
