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FDA Veteran Paz Vellanki, MD, joins Precision to become one of 3 ex-FDA oncology leaders supporting clients

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Jo-Ann, Gonzales, RAC Avatar

Jo-Ann Gonzales, RAC

Jo-Ann Gonzales, RAC, is a Senior Director of IVD Regulatory Consulting within Precision for Medicine’s Translational and Regulatory Sciences Practice, bringing more than 25 years of U.S. and international regulatory affairs experience. She has deep expertise across the full IVD development lifecycle, including next-generation sequencing and companion diagnostics, with a focus on regulatory strategy and submissions for a wide range of assays such as non-invasive prenatal testing, infectious disease donor screening, oncology, and respiratory viral diagnostics. Her experience includes FDA Emergency Use Authorization (EUA) submissions for SARS-CoV-2 tests, Pre-Submissions, IDEs, De Novo, PMA, and 510(k) applications, as well as review of labeling, advertising and promotional materials, analytical and clinical study design, and use of FDA eSTAR templates. She is also well-versed in regulatory considerations for instrument platforms and software components.
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