For those of us on the West coast, it was an early wakeup this morning, but well worth it! Here are some highlights from the GRx-Biosims conference morning sessions. Dr. Sally Choe, Director, Office of Generic Drugs (OGD), opened the morning with the OGD keynote address. Dr. Choe outlined the OGD’s performance during the pandemic, indicating that […]
The other session that I was able to monitor was the Cares Act – Additional Reporting Requirements for Manufacturers. The purpose of the new reporting requirements is to proactively identify potential drug or API shortages so that the FDA can begin to act and perhaps institute a flexible regulation approach to mitigate the shortage. The […]
Since I am not a superhero and am unable to be in two places at once, I had to choose which of the afternoon sessions I would attend. With one of the hot topics being the inspectional issues raised by the COVID-19 pandemic, I chose to sit in on the Post-COVID Inspection World: New Tools, […]
Another busy schedule for another virtual meeting. AAM has indicated that it will be back to in-person meetings with the February 2022 annual meeting. We are all looking forward to being able to shake hands, see each other in person, and chat face-to-face. Don’t know about you but, for me, virtual meetings just don’t have […]
Today, FDA issued a Federal Register notice (here) announcing the release of 24 new product specific guidances (PSGs) and 20 revised guidances. These guidances provide the FDA’s current thinking on the methods to establish bioequivalence for specific products. The new and revised guidances can be found on the FDA webpage here. Please note that, as […]
The FDA is changing its reporting requirements for GDUFA III. It appears from the changes that some information may be more difficult to gather and will be removed from the monthly Generic Drugs Program Activities Report we have all come to love and will be moved to either quarterly or annual reports. The monthly report […]
On November 2, 2021, FDA posted an update to the Memorandum of Understanding (MOU) Addressing Certain Distributions of Compounded Drugs (here). FDA notes that it was sued by seven compounding pharmacies (503A compounders) in US District Court regarding the 5% limitation on the out of state distribution of compounded products by pharmacies in states that […]
We have done a number of posts on the FDA’s activities with regard to assuring the safe use of benzodiazepines (here, here, and here, where we discuss issues regarding increased warnings and potential REMs, and even the specter of abuse-deterrent formulations being applied to benzodiazepines (here)). While no one knows where this will end up, […]
According to the FDA All Approval list, OGD reported 28 full approval actions and two (2) tentative approval actions thru 10AM ET on October 15, 2021 (here) for a total of 30 approval actions midway through the month. This is a more favorable figure than we reported for the midway point of September (here) where […]
Well, we have been seeing certain information on ANDA suitability petitions since FDARA passed, but only the information required by the Act. The FDA reports a separate list of petitions that have been filed, those that are pending, or those that have been acted upon. Unfortunately, according to the FDA page where the list resides […]
