January 4, 2011
At nearly the end of 2010, the FDA published the tentative calendar for advisory committee meetings for 2011. Naturally, the agency cannot precisely detail the calendar at this stage, but it does provide a bit of a signal regardomg the … Continue reading →
December 13, 2010
As noted in the Weekly Roundup on Friday, last week the FDA published a Final Guidance on the Open Public Comment period at FDA Advisory Committee meetings. On a side note, it is perhaps worth noting that this updated the … Continue reading →
April 29, 2010
In June of 2008, January of 2009 and again in June 2009 the General Accounting Office issued reports on the FDA and its oversight of medical devices. The June 2009 report echoed findings from the earlier January report, put forth a recommendation … Continue reading →
April 12, 2010
i-Pad, therefore i-Am. A colleague asked me the other day – what is so special about the i-Pad that you don't already get on your phone or your laptop? I responded by saying that right now, in computing, … Continue reading →
January 14, 2008
One of the many lessons available from the track record of the FDA last year involves communications and preparation for advisory committee and FDA approvals. There increasing numbers of approvable letters than there were declines in approvals last year. There … Continue reading →