FDA to Develop Standards for Safety Biomarker Qualification

February 25, 2016

On Thursday, February 25th, FDA announced plans to hold a public workshop to discuss the evidentiary standards necessary to support biomarker qualification. The workshop, entitled “Developing an Evidentiary Standards Framework for Safety Biomarkers Qualification Workshop,” will be conducted over two days and will place an emphasis on drug safety markers. Furthermore, the FDA states that the workshop “will focus on the standards relevant to the qualification of a range of safety biomarkers and examine case studies in several different organ systems.”


Via the Critical Path Initiative, the FDA identified the need for evidentiary standards to qualify biomarkers, determining this to be “essential to improving the efficiency and effectiveness of drug development.” According to the FDA, the evidentiary standards associated with different types of biomarkers vary from one to another. As such, FDA has stated that there are a number of specific challenges involved in qualifying drug safety biomarkers, which is one of the primary reasons there is such an immediate need for a system to do so.

Public Workshop

In holding this workshop, FDA’s goal is to create alignment among scientific stakeholders to support a proposed framework to determine the evidence needed to qualify biomarkers for use in drug development. In order to achieve this goal, attendees will discuss the development of a general framework for biomarker qualification, as well as specific application of the framework to different context(s) of use related to drug safety.

The stakeholders involved in this workshop include FDA, NIH, the biopharmaceutical industry, academic researchers, and patient groups.

The workshop will be held in Bethesda, Maryland, on April 14th and 15th from 8am to 5pm. Although there is no fee associated with attendance, the Agency is requiring participants to register in advance. The deadline for registration is April 1st. Due to the limited space that is available, registration is on a first-come, first-served basis. As such, if you are interested in attending the workshop it is advised that you register online as soon as possible.

The Weinberg Group has a 35-year track record of helping our clients achieve successful interactions with the FDA and we have the experience you need to do exactly that.  Contact us today to learn more about our services and how we can help you develop and submit a successful application.


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