The U.S. Food and Drug Administration Guidance Snapshots
The U.S. Food and Drug Administration (FDA) has launched its Guidance Snapshot Pilot, aiming to disseminate the Agency’s current best thinking on topics that seek to accelerate drug development and modernise clinical trials.
BioCurate recommends that those wishing to translate their research read these Guidance Snapshots, as they provide an accessible entry point to understand the fundamental concepts critical for success.
The Guidance Snapshots provide pertinent highlights from, and are intended to increase awareness and engagement of, FDA guidance documents on innovative topics, and to support the efficient application of the documents’ recommendations.
In Vitro DDI Guidance Snapshot
The In Vitro Drug-Drug Interactions (DDI) Guidance Snapshot summaries the In Vitro Drug Interaction Studies – Cytochrome P450 Enzyme-and Transporter-Mediated Drug Interactions Final Guidance, outlining a general framework for conducting in vitro experiments and interpreting in vitro study results to determine the potential clinical DDIs.
It is important for academic researchers to ascertain any potential clinical DDIs in pre-clinical studies as patients frequently use more than one medication at a time. Unanticipated, unrecognised, or mismanaged DDIs are a major cause of morbidity and mortality associated with prescription drug use and have occasionally caused the withdrawal of approved drugs from the market.
Targeted Therapies Guidance Snapshot
The Targeted Therapies Guidance Snapshot summaries the Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease Final Guidance, outlining important recommendations on the development of targeted therapies (treatments that address molecular alterations) and, the type and quantity of evidence that can demonstrate efficacy across patients with different molecular targets.
Given the nature of targeted therapies and the potential to be fast-tracked through regulatory processes, it is critical for academic researchers to be aware how to best evaluate the benefits and risks of targeted therapies in subsets of patients with specific molecular alterations within a clinically defined disease that do not occur frequently as this makes them difficult to evaluate. Taking these recommendations into account during pre-clinical studies will create a more robust data set.