Overview of FDA Expedited Development and Approval Programs for Serious Conditions
Impact Pharmaceutical Services
MAY 4, 2022
Image courtesy of qimono at pixabay.com. Concepts and definitions including “serious condition,” “available therapy” and “unmet medical need” are detailed in FDA’s guidance documents and are threshold criteria generally applicable for concluding if the product is a candidate for these programs. Image courtesy of geralt at pixabay.com.
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