FDA guidance on patient-focused drug development

FDA wants drugs to be more targeted to factors that impact patient’s lives in ways that they care about. To achieve this goal, last month FDA released a third guidance document on patient focused drug development generally applicable to a variety of clinical outcome assessments (COAs), including patient-reported outcome (PRO), observer-reported outcome (ObsRO), clinician-reported outcome…

FDA Guidance: Methods for identifying what is important to patients

What disease components are most burdensome to patients? How do researchers find this information out? To answer this question, the Food and Drug Administration (FDA) recently put out its second guidance document on Patient-Focused Drug Development: Methods to Identify What Is Important to Patients. A few qualitative approaches they recommend to collect this information include:…

Overview of FDA Drugs Approved in 2021

In 2021, the Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) approved 50 new drugs, either as new molecular entities (NMEs) under New Drug Applications (NDAs), or as new therapeutic biologics under Biologics License Applications (BLAs). FDA summarizes these approvals in their recently released report titled: Advancing Health Through Innovation: New Drug…