Review of New Drug Application for Bronchitol (dry powder mannitol)
Decision: Negative Recommendation
This meeting was live webcast and the recording has recently been made available by the FDA.
Click on the links below to access the recordings or additional materials.
Recording of the Open Public Hearing
Highly recommended for anyone with a personal or professional interest in CF. This section is not part of the formal evidence but includes short speeches by people with CF, specialist CF physicians and senior representatives from the CF Foundation and CFRI designed to give the committee additional context and a patient perspective.
Full webcast information
I wrote a commentary on this meeting and posted it here on February 10, 2013:
Bronchitol: Power to the Patient
And this follow-up post on the same day:
Bronchitol: Future Prospects in the US