(UroToday.com) The Society of Nuclear Medicine & Molecular Imaging (SNMMI) 2021 Annual Meeting included a session on FDA Radiopharmaceutical updates and a presentation by Drs. Shane Masters and Sue Jane Wang discussing clinical trial design and statistical considerations for PSMA PET drug development. Dr. Masters notes that “Guidances by the FDA” are the FDA’s current thinking on a topic and are not legally binding documents. Furthermore, a ‘Guidance for Industry’ includes both academic and commercial sponsors.

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