FDA Considers Cuts And Initiatives For Fiscal 2014 – Hamburg
This article was originally published in The Tan Sheet
Executive Summary
Commissioner Hamburg tells FDA’s Science Board that in the early stages, both cuts and expansions are on the table as the budget process begins in preparation for the fiscal year starting October 2013.
You may also be interested in...
FDA’s Generic Drug Office Goes On Diet Before Swallowing User Fees
Congress sets $52.9 million floor for Office of Generic Drugs in FY 2012, less than in 2011, as part of $3.8 billion FDA funding package. Overall, FDA gets a $50 million boost, but sequestration looms. Appropriations conferees enter the user fee debate, asking how fast FDA approves drug applications.
Mary Beth Clarke, CDER Exec Programs Office Director And Generic User Fee Shepherd, Will Retire
Clarke helped launch GDUFA I and negotiate GDUFA II, chaired the CDER Executive Committee and oversaw many other programs in the US FDA’s drugs center.
Gene Therapy: Pediatric Development Could Start Sooner Than Sponsors Think – FDA OTP Director
Nicole Verdun said children could participate in gene therapy clinical trials earlier if the necessary controls are in place.