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 […]
Every 5 years, the user fee programs (UFAs) are renegotiated and, for each UFA program, there is a commitment letter that outlines the agreed-upon goal dates and program enhancements that will dictate the five-year reauthorization period when Congress passes the Reauthorization Act (likely in mid to late FY 2022). This is a piece of must-pass […]
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, […]
In my October 5, 2021 post (here), I discussed what appeared to be a significant dip in ANDA approval and tentative approval actions, as well as a decrease in the number of ANDA submissions. I mentioned that I did not have further insight as to the decline in these metrics but did mention that maybe […]
Tomorrow, FDA will issue a revised draft guidance on Hearing Aids and Personal Sound Amplification Products (PSAP) (here), and is also publishing a proposed rule for the over the counter (OTC) classification of hearing aids (HA) and PSAP (here) entitled “Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids”. These are the prepublication […]
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 […]
Overnight, FDA updated its metrics for August and also provided some critical metrics to end out FY 2021 (here). Let’s take a look at the August update first. OGD issued three (3) Refuse-to-Receive letters in August, which appears to be consistent with the numbers for the year (with the exception of 11 RTRs that were […]
In a prepublication Federal Register (FR) notice (here), the “Food and Drug Administration (FDA or Agency) is announcing the withdrawal of three guidance documents titled ‘Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19),’ ‘Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health […]
