Committee Clear On Need For Fracture Data For New Calcitonin Drugs
A March 5 FDA advisory panel gave a mixed assessment of whether nasal spray formulations of the products should remain on the market for postmenopausal osteoporosis, but overwhelmingly agreed that new versions should meet a higher efficacy standard.
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Patrizia Cavazzoni, Janet Woodcock's new #2, has a background similar to Richard Moscicki, CDER's previous deputy director for operations.
Industry also seems supportive of the idea, while Pew touts the power of the power of track-and-trace as a deterrent.
EMD Serono has been tracking Serostim packages since 2002; J&J is using Prezista 600 mg as a trial run for serialization.