Defining Exacerbation Could Produce Endpoint For Non-Cystic Fibrosis Bronchiectasis, FDA Told
This article was originally published in The Pink Sheet Daily
The agency received input on the natural history of the disease and options for measuring exacerbation to assess therapeutic success during a Sept. 7 workshop.
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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.