FDA’s New Orphan Products Director Brings Industry, Legal, Academic, Regulatory Background
Sandra Retzky worked at AstraZeneca and in Delaware's Medicaid fraud unit before joining the US FDA in 2016.
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OOPD’s deputy director has been named the acting head of the office responsible for orphan and rare pediatric disease designations.
US FDA-related legislation among the bills moving during the lame duck session of Congress.
Rare Pediatric Disease Designations May Be Unavailable After July As Program Renewal Remains Uncertain
Without new legislation, US FDA said that designations, which are required to receive priority review vouchers, cannot be assured if requested after July. While the window for designations formally closes at the end of September when the authorization of the program expires, the agency is telling sponsors that it needs 60 days before that to review any requests. If a product does get a designation, it would need to secure approval by 30 September 2022 to gain a priority review voucher.