Government closing’s effect on user fee dates
FDA's Center for Biologics Evaluation & Research and Center for Drug Evaluation & Research are taking different approaches to June 11 government closing for day of mourning for President Reagan. CBER is treating June 11 as a holiday and will not extend any user fee dates. CDER is treating the office closure like any other unexpected closing (e.g., weather) and will extend user fee goals that fall near the date of closure on a case-by-case basis. Drugs with user fees near the closure include Cardiome's Oxyprim (oxypurinol) (June 23) and Ivax' Easi-Breathe (albuterol/beclomethasone) CFC-free inhaler (June 29). The agency cancelled its public meeting covering agency regulations on electronic records and signatures in part 11 and the second day of its anthrax targeted therapy development workshop scheduled for June 11...
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