Draft guidelines for validating treatment processes

A public meeting is also planned “to obtain patients’ and caregivers’ perspectives on the impacts of rare diseases on daily life” that might help in the development of new treatments and in improving clinical trials. “The FDA is committed to supporting the development of treatments for patients with rare diseases and has been focused on advancing policies that will help enable these opportunities,” Scott Gottlieb, the agency’s commissioner, said in a releasethat accompanied the draft guidance. discusses select issues commonly encountered in rare disease drug development,” Gottlieb added.

“While similar issues often also come up for common diseases, they’re frequently more difficult to address in the context of a rare disease for which there’s often limited medical and scientific knowledge.” When finalized, the guidance will present the agency’s current thinking on the topic.

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Its 24 pages include discussion of issues in evaluating and validating biomarkers as surrogate endpoints (the outcomes a clinical trial measure therapy effectiveness against), non-clinical aspects of evaluating treatment compounds, a new section on the evaluation of safety questions, and additional information on changes to a medicine’s compounds or product manufacturing processes.

It was issued by the FDA’s Center for Drug Evaluation and Research (CDER), and its Center for Biologics Evaluation and Research (CBER).

The agency recommends that natural history studies be of sufficient duration, select data elements based on disease features, collect data from a variety of sources, include patients across a wide spectrum of disease severity and phenotypes (observable clinical traits), and use standardized collection methods and medical terminology.

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