This week, the FDA issued several guidances that lay out the agency's current thinking and advice to industry on important topics.
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Evaluation of Sex-Specific and Gender-Specific Data in Medical Device Clinical Studies: A draft guidance encouraging the consideration of sex and/or gender in the design of medical device clinical studies and reporting data. This document aims to update the 2014 guidance by addressing both sex- and gender-specific data.
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Developing Drugs for Optical Imaging: This draft guidance provides recommendations on the design of clinical trials for optical imaging drugs used during surgery to detect tumors or delineate normal anatomical structures.
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Action Levels for Lead in Processed Food Intended for Babies and Young Children: A final guidance supporting the Closer to Zero initiative to reduce dietary exposure to lead, aiming for sustainable reductions while maintaining access to nutritious foods.
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Animal Food Ingredient Consultation (AFIC): A final guidance detailing the FDA's intention to conduct voluntary consultations with firms developing animal food ingredients through the AFIC process.
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Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway: A draft guidance describing the FDA's interpretation of the term "underway" and policies for implementing this requirement for drugs granted accelerated approval.
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Study of Sex Differences in the Clinical Evaluation of Medical Products: A draft guidance providing recommendations for increasing female enrollment in clinical trials, analyzing sex-specific data, and including sex-specific information in regulatory submissions.
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Considerations for Including Tissue Biopsies in Clinical Trials: A draft guidance aimed at assisting industry and clinical investigators in understanding considerations for tissue biopsies in adults and children as part of clinical trials evaluating investigational medical products.
These guidances reflect the FDA's ongoing efforts to enhance clinical trials, improve participant safety, and further clinical research.
