FDA Issues Reports on Communication and Guidance Document Best Practices

Policy & Medicine December 4, 2024
Thomas Sullivan

The US Food and Drug Administration (FDA) has published reports on communications and guidance documents as mandated by Congress in the Consolidated Appropriations Act of 2023. These documents detail the FDA’s proposed strategies for enhancing communication with stakeholders and refining the development and issuance of guidance documents, informed by the agency’s experience during the COVID-19 pandemic.

Evaluating FDA’s Communication Enhancements

The report delves into the FDA’s revised strategies for communication, aimed at improving transparency and effectiveness in interactions with stakeholders from the pharmaceutical and medical device sectors. It suggests adopting new digital communication tools and enhancing the clarity of regulatory expectations. These proposals are designed to help stakeholders navigate regulatory processes more efficiently, though their practical impact remains to be...

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