FDA

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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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 on structured benefit-risk (B-R) analyses as a core part of regulatory thinking. See links below along with the core paper from the FDA’s website on benefit-risk (oddly, the NEJM paper is not

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Final FDA Unmet Need Guidance!

Dear All:  Just out in the last 24h is the announcement that FDA’s 2013 Unmet Need Guidance has now been released in final form. The associated FR guidance is also worth reading as it provides a summary of what has been updated: “This guidance finalizes the draft guidance of the same name issued July 2, 2013 (78 FR

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16 Nov FDA AdComm – Inhaled ciprofloxacin for non-CF bronchiectasis

Dear All:  A Federal Register notice has been released announcing a 16 Nov 2017 FDA Antimicrobial Drugs Advisory Committee meeting to review Bayer’s inhaled ciprofloxacin for reduction of exacerbations in adults with non-cystic fibrosis bronchiectasis with respiratory bacterial pathogens (NCFB). Post-meeting addendum: Materials from the meeting can be found here. You might also want to look at materials from

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7 Nov 2017 FDA VRBPAC: Clinical development plan for a S. aureus vaccine

Addendum: This is the first in a 3-newsletters series on this topic. Go here and here for the next two newsletters. Dear All:  I just learned that FDA’s Vaccines and Related Biological Products Committee (VRBPAC) will meet at White Oak in an open session on 7 Nov 2017 to discuss and make recommendations on the clinical

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Summary of funding initiatives (Simpkin et al.) + E9(R1) Statistical methods update (FDA)

Dear All: Two updates today. First, our colleagues at London School of Economics have just published a review of antibiotic innovation incentives that includes a detailed review of some of the currently available sources of funding (Simpkin VL et al., Incentivising innovation in antibiotic drug discovery and development: progress, challenges and next steps. J Antibiot, 1 Nov 2017). As

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7 Nov 2017 FDA VRBPAC: Pfizer’s S. aureus vaccine — do results in one population generalize?

Addendum: This is the second in a 3-newsletters series on this topic. Go here for the first newsletter and here for the final newsletter. Dear All:  I wrote on 19 Oct 2017 about the meeting on 7 Nov 2017 of the Vaccines and Related Biological Products Committee (VRBPAC) at White Oak to discuss Pfizer’s investigational Staphylococcus aureus vaccine intended

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