Allphase Pharma Consulting, LLC
A Professional Service Provider for the Pharma Industry
The QIDP designation was introduced in 2012 to incentivize drug development in antiinfectives. QIDP came with several attractive features, such as prolongation of patent life, FDA expedited review and more. In addition, FDA made it quite easy to garner the label. As you can see, there is really no downside to Continue reading Prospecting for New Antibiotics
According to Janet Woodcock, 63 drugs have been given the “QIDP” designation so far. Our inofficial list has 61 drugs, of which we believe only 57 are still in active clinical development. So we are in fairly close agreement. That may seem like an impressive record but it is also Continue reading QIDP Drug Update – Part 2: Categories of Interest
Very recently we came across several studies in which small differences in design had a major impact on outcomes. A blog is not a good place to dig deeply into the minutiae of study design as the discussion becomes quickly very dry and quite technical. However, readers and clinicians are often unaware how a seemingly small change Continue reading Is LAIV Dead or Just on LAIV-Support?