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Decentralized Clinical Trials Among Topics Slated For CDER Guidance In 2020

 
• By Brenda Sandburg

US FDA's to-do list also includes guidances on development of non-opioid analgesics and cannabis compounds, evaluation of generic therapeutic equivalence, and pediatric product development.

Vintage hourglass on yellow background with to do list in 2020 text.
FDA issues list of guidances it plans to publish this year

The US Food and Drug Administration plans to offer sponsors more guidance on clinical trial issues this year, including in the areas of pharmacogenomic data submission and use of digital health technologies.

The Center for Drug Evaluation and Research's 2020 guidance agenda of new and revised draft guidances it plans to publish during the calendar year covers 14 categories

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