Suitability Petitions


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 […]

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