Drugs

Endpoint Clinical Outcome Assessment Guidance

FDA has published a draft guidance, Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments into Endpoints for Regulatory Decision-Making, which is the last in a series of four methodological patient-focused drug development guidances that describe how stakeholders can collect and submit patient experience data and other relevant information from patients and caregivers to be used for medical product development and regulatory decision-making. The document covers methods, standards, and technologies for collecting and analyzing clinical outcome assessment (COA) data for regulatory decision-making, including selecting the COA-based endpoint and determining a clinically meaningful change in that endpoint.

FDA says it encourages stakeholders to interact early with the agency and obtain feedback from the relevant review division when considering the collection of patient experience data related to the burden of disease and the benefits, burdens, and harms of treatment.

The draft contains an Introduction, COA-Based Endpoint Considerations, Evaluating the Meaningfulness of Treatment Benefit, Additional Considerations, and References.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome