Howard Sklamberg is a partner at Akin Gump Strauss Hauer & Feld LLP. From 2014-April 2017, Howard served as USFDA’s Deputy Commissioner for Global Regulatory Operations and Policy, where he oversaw the Office of Regulatory Affairs and the Office of International Programs. He led or co-led many quality and safety efforts (including inspection modernization and program alignment) and the negotiation and implementation of GDUFA and GDUFA II. Howard directed FDA’s multilateral initiatives and its overseas offices. Howard also served as Direction of CDER’s Office of Compliance and Deputy Associate Commissioner for Regulatory Affairs.