Getting to First-in-Human for Small Molecules and Biologics

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  • Опубликовано: 25 авг 2024
  • Whitney Helms, PhD, from FDA’s Division of Hematology, Oncology, Toxicology, in the Office of Oncologic Diseases at CDER, discusses guidance documents and nonclinical expectations for initiating trials and developing small molecule and biologic products for oncology products, as well as common misconceptions and stumbling blocks.
    Learn more at: www.fda.gov/dr...
    -------------------- 
    FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.  
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