Allphase Pharma Consulting, LLC
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For the latest QIDP listing, please click HERE Our latest internet search came up with 37 drugs that garnered QIDP status. They are listed in the Table below (if I missed a compound, please leave a comment!!). The table is searchable so you should be able to massage the data to Continue reading Drugs with QIDP Designation – Update 4/8/2015
“The medicine comes for free, just pay us for the inhaler” should be the marketing slogan for this group of therapeutics. Nebulizers are good business: hard to copy as a delivery system, they are a great opportunity to ‘evergreen’ off-patent antibiotics. The inhalational route to administer antibiotics is clearly attractive. Continue reading Aerosolized Antibiotics & Selling Nebulizers
Just to refresh everyone’s memory: First, we had the Points-To-Consider document of 1993, then the 1998 Guidance, followed by the 2012 Guidance and now the 2015 Guidance for the conduct of registration studies in cUTI. They all have served us well and I cannot recall a situation when a drug Continue reading The New cUTI Guideline: A Look at the ‘Evolving Thinking’ at FDA