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Ajaz Hussain Leaving FDA for Sandoz
Ajaz Hussain, the high-profile deputy director of the US Food and Drug Administration’s Office of Pharmaceutical Science (OPS), is leaving the agency on Oct. 28 to join Sandoz (Holzkirchen, Germany) as vice-president and global head for biopharmaceutical development.
In a Tuesday-evening announcement, OPS Director Helen N. Winkle called Hussain “the tireless champion of pharmaceutical product quality and a leader of numerous initiatives in FDA such as the 'Pharmaceutical CGMPs for the 21st Century-A Risk-Based Approach’” and “architect of CDER's Process Analytical Technologies efforts.”
Earlier in his FDA career, Hussain played key roles in the Center for Drug Evaluation and Research’s (CDER) Scale-up and Postapproval Changes (SUPAC) and Biopharmaceutics Classification System (BCS) initiatives.
Sandoz, the generics subsidiary of Novartis, sued FDA on Sept. 13, trying to force FDA to rule on the company’s follow-on biologic application for “Omnitrope,” a recombinant human growth hormone. For more information.