FDA

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 have released a summary of their third tripartite meeting. The key message is alignment: alignment on trial designs for key indications, alignment on pediatric programs, and alignment on single global development programs! This is

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BARDA’s DRIVe goes live; FDA workshop (27 Jun!) on inhaled antibiotics

Dear All: I don’t mean to inundate your inbox (this is my 3rd email this week!), but these two things have just hit my inbox and one of them has very tight timing: First, I previously wrote about job opportunities with BARDA’s new DRIVe initiative. With the goal of revolutionizing the way we prevent, detect, and respond to major health security threats,

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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 workshop on the development of non-traditional antibacterial agents was an excellent discussion of core challenges in this area. The agenda plus all the meeting materials (including the public comment slides and

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Commissioner Gottleib (New FDA initiatives, need for Pull incentives) + updated Pew pipeline analyses

Dear All: It was a HUGE day at the Pew Charitable Trusts today! First, Commissioner Scott Gottleib gave a superb and very exciting speech. You can either read or listen to the entire speech. There is also a panel discussion after his talk that is worth replaying. Here are some highlights from Commissioner Gottleib’s talk: FDA is working to coordinate

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Pew’s SPARK goes live / FDA on Master Protocols and Adaptive Designs / CDC’s Fungal Awareness Week

Dear All: Potpourri! Four things of note… First, Pew’s SPARK (Shared Platform for Antibiotic Research and Knowledge) has now gone live. Seeking to address a core issue in Pew’s Scientific Roadmap for Antibiotic Discovery, SPARK is a cloud-based sharing tool for data on how molecules enter and stay inside of Gram-negative bacteria. To learn more, mark your calendar

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