FDA

Using Real-World Evidence: FDA Workshop on 13 Sep 2017

Dear All:  There is a newly announced FDA workshop on 13 Sep on using real-world evidence. Here is the link and I’ve also reproduced the key background text below my signature. This is of interest to the antibacterial community as our reliance on non-inferiority trials for the majority of our data means that we are often going to want

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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 of surrogate endpoints that can be considered for use by developers: The public docket soliciting comments is here. The web page providing an overview of surrogate endpoints and biomarkers is here. The surrogate

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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 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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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 teaser from the web: “Convened by the Duke-Robert J. Margolis, MD, Center for Health Policy at Duke University and supported by a cooperative agreement with FDA, this public event will

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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 has now announced a 20 Mar 2018 workshop on complex innovative designs (CID) in clinical drug trials. From the Federal Register notice, we are told that the workshop seeks to (1) facilitate

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Sunday 10 Jan: UCSF-Stanford regulatory conference with FDA

Dear All, New on the meetings calendar today is the 10 Jan 2021 UCSF-Stanford Innovations in Regulatory Science Summit. Per the meeting website: “It is a gathering of leaders in the academia, industry and regulatory sectors to discuss the role of regulatory science in medical product development.   “The 2021 Summit will have a major focus on

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FDA offers 2 fellowships and 3 RFPs! Endpoints, breakpoints, PROs & more!

Dear All, Our colleagues at FDA are planning some serious AMR-related research during 2021-22 with the following fellowships and RFPs. Extended details are available via the links — you can also find brief summaries below my signature or via FDA’s research webpage. Wow! FDA Fellowship #1: A study of ordinal endpoints for antibiotic trials using

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FDA-NIAID-CDC: Developing drugs for gonorrhea, 23 Apr 21 workshop

Dear All, FDA, NIAID and CDC have announced a public workshop on development considerations of antimicrobial drugs for the treatment of gonorrhea. The workshop will cover both nonclinical (preclinical) and clinical trial design considerations: Animal models Clinical pharmacology considerations Trial design considerations for gonorrhea, such as enrollment strategies, choice of comparators and site of infection.

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