Friday, 22 February 2013

Bronchitol™ - FDA Webcast

January 30, 2013 Meeting of FDA Pulmonary-Allergy Drugs Advisory Committee (PADAC)

Review of New Drug Application for Bronchitol (dry powder mannitol)
Sponsor: Pharmaxis
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.

Meeting Agenda

Briefing Materials

Presentation Materials

Full webcast information

Additional Information

Meeting Minutes

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

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