Today we address what might seem like an ongoing problem with no end. I refer to the submission of unsolicited amendments by DMF holders during an ANDA review cycle. If the DMF holder is unaware of the status of an ANDA and they do submit an unsolicited amendment, it could delay the review cycle or […]
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 […]
I know that I have written about this issue multiple times (here and here; also search our blog for other data integrity posts) and I guess it is a holdover from my time at FDA and living through the generic drug scandal of the late 1980s, but, come on now, folks, the FDA’s bark seems […]
