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Agency plans new guidance in traceability, REMS and biosimilarity, among others
Just before the snows shut down Washington last weekend, FDA issued its annual list of intended guidance documents across the range of regulatory functions it oversees. Some of these come about through legislation; some are agency-generated when a gap in FDA policies is realized. The agency strives to meet its schedule—under transparency recommendations from former Administrator Margaret Hamburg—but the deadlines get missed, and the guidances that are issued are sometimes not quite what was expected. Guidances are not “law;” but FDA promulgates these documents with the expectation that the goals they define will be met in one or another fashion.
At any rate, the 102 intended guidances range from major industry practices to specialized therapeutic areas. Some of the highlights:
It’s going to be a busy year.