February 2, 2016
On January 28, 2016, an FDA and NIH Joint Leadership Council published its first official glossary of terms and definitions, which “clarifies important definitions and describes some of the hierarchical relationships, connections, and dependencies among the terms it contains.”
In the past, there have been a number of definitions and terms that have been used inconsistently. This has created difficulties for drug development programs by hindering the evaluation and interpretation of scientific evidence. Due to this ongoing issue, the leadership council came together in the spring of 2015 to construct a list of terms that are “used in translational science and medical product development as a priority need, with a focus on terms related to study endpoints and biomarkers.”
With a number of goals established, including “improving communication, aligning expectations, and improving scientific understanding,” the council worked together to develop the BEST (Biomarkers, EndpointS, and other Tools) Resource. The first phase of BEST consists of a glossary of clinical terms and definitions. The glossary “aims to capture distinctions between biomarkers and clinical assessments and to describe their distinct roles in biomedical research, clinical practice, and medical product development.” Furthermore, in the announcement made regarding the publication of the BEST Resource, the working group stated that:
“Because the glossary is intended to be broadly applicable to multiple communities of users and stakeholders, its definitions address nuances of usage and interpretation for a wide variety of terms currently in use. Further, based on differing stakeholder needs, it has built in flexibility, when possible and appropriate, to accommodate those interests. NIH and FDA intend to use the definitions included in this glossary when communicating on topics related to its contents (e.g., biomarkers) to ensure a consistent use of the terms and therefore, a common understanding of the issues.”
The council envisions the glossary to be a “living” resource and states that it will be periodically updating the document to clarify information and add supplementary terms. The council welcomes feedback from all stakeholders, including the scientific and medical communities, patients, providers, industry, and regulators. Feedback will be considered on a regular basis and will be used to assist the council as it refines and elaborates on the terms to ensure that the glossary remains relevant.
May 5, 2017
On Monday, May 1st, the FDA approved Imfinzi™ (durvalumab). Imfinzi is manufactured by AstraZeneca, and it is a PD-L1 inhibitor indicated for the treatment of patients with locally advanced or...
May 25, 2017
On Tuesday, May 23rd, the FDA granted accelerated approval to Merck & Co.’s Keytruda® (pembrolizumab), a product to treat cancers with a specific genetic feature (also known as a biomarker)....
June 25, 2018
On Monday, June 18th, FDA introduced two initiatives intended to increase access to generic drugs and promote generic competition. The Agency requested $37.6 million in fiscal year 2019 to fund these...