Dear All: FDA has today released an initial draft of its guidance on LPAD (Limited Population Pathway for Antibacterial and Antifungal Drugs). You may recall that the August 2017 Guidance
Dear All: First up, NIAID has released a BAA (Broad Agency Announcement) regarding up to $15.5m in funds for awards in two research areas. Here is a brief
Dear All, Two important new research calls are now out. First, FDA is offering research funding of up to $1m to support creation of rabbit models
Dear All: An article by Gassman, Nguyen, and Joffe in today’s NEJM entitled “FDA regulation of prescription drugs” caught my eye because of its emphasis
Please be sure to look closely at the events calendar: Q&A with Scott Gottlieb, Lipinski on Lipinski, and more! Dear All: FDA’s 21-22 Aug 2018
Dear All: Several updates today, all on the theme of good things to know or share! First, EMA, FDA, and PMDA are continuing to meet and
Dear All: I knew that the idea of an online and frequently updated website for FDA-recognized Susceptibility Test Interpretive Criteria (STIC) was brewing based on
Dear All: Adding to the 19 Mar 2018 (Designs for Rare Diseases) and 16 Apr 2018 (Inclusion/Exclusion criteria) workshops already announced (see list below), FDA
Dear All: Duke-Margolis and FDA have now announced a 19 Mar 2018 workshop entitled Utilizing Innovative Statistical Methods and Trial Designs in Rare Disease Drug Development (FR notice). Here’s the
Dear All: On Wednesday 6 Sep at the ASM-ESCMID Conference on Antibacterial Development, we heard 3 superb back-to-back talks on the evolving regulatory and health technology