FDA-approved surrogate endpoints for developers
Dear All: As requested by Congress as part of the 21st Century Cures Act, the US FDA has now released for public comment a table
2 November 2018
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FDA
NIAID Funding opportunity + FDA guidance x 3: revisions for cIAI and cUTI + new for uUTI (draft)
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
5 June 2018
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Two research calls: FDA (rabbit VAP models) and JPIAMR (aquatic pollutants)
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
22 December 2019
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Benefit-Risk analyses: Gassman et al. (NEJM) + FDA
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
16 February 2017
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FDA workshop on non-traditional antibacterials (21-22 Aug 2018)
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
23 August 2018
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EMA-FDA-PMDA action + Podcasts (CDD, Pew) + NEJM on non-inferiority
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
21 November 2017
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Debut of FDA Susceptibility Test Interpretive Criteria (STIC) website
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
13 December 2017
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(Another!) FDA trial design workshop: Complex innovative designs
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
24 February 2018
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Duke-Margolis & FDA: Workshop on stats & methods for rare diseases
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
14 February 2018
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Updates from EMA, FDA, and UK NICE at the 6-8 Sep 2017 ASM-ESCMID Antibiotic Development Conference
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
8 September 2017
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