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FDA advisors Wednesday urged the agency to rescind the OTC bronchodilator monograph for epinephrine and racepinephrine products delivered via a hand-held rubber bulb nebulizer, saying the combination products present safety concerns that only an NDA can address. Read More
Devicemakers planning a PMA or product development protocol should take advantage of presubmission determination meetings with the FDA to pin down exactly what data the agency expects to support safety and efficacy of a new product. Read More
CDRH plans to reduce the number of IDEs requiring more than two cycles to make a determination by 25 percent by Sept. 30, and by 50 percent by June 30, 2015. The aim is to get the median time for full IDE approvals down to 30 days by June 30, 2015. Read More