This article was originally published in The Gold Sheet
More FDASIA reorganizations at FDA; Key QbD elements expected in ANDA supplements.
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The reorganized ORA has eight new offices to better handle new legislative authorities and globalization of its regulated products; FDA expects to increase partnerships with other government officials and foreign entities.
In the two months since the enactment of the Generic Drug User Fee Act, FDA has announced a major recruitment from the brand sector to head its generic drug activities (Gregory Geba), approved one controversial transdermal generic (Watson’s lidocaine topical patch), and elevated the generic review activities to “Super Office” status.
The USP’s general chapter on nitrosamine impurities provides guidance on assessing risks and testing levels of the carcinogens in pharmaceuticals.