Suitability Petitions

31
Oct

OGD Published GDUFA III Commitment Letter

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 […]

Read More
11
Oct

Holy Cow, Revised MaPP on ANDA Suitability Petitions – Now What Does This Mean?

Well, in my book, any movement on 505(j)(2)(C) ANDA suitability petitions is welcome news.  The pool of pending ANDA suitability petitions is full at FDA and is, by now, becoming very stagnant.  There has been little action on 505(j)(2)(C) petitions in the last 10 years.  Just last year, out of the blue, we got two […]

Read More