Clinical Pharmacology Drug Development Workshop 
FDA Law Blog: Biosimilars
JULY 17, 2024
These are exactly the types of things that were addressed at ELF Scientific Workshop in May 2024 which addressed challenges in developing therapies for ultra rare diseases (see our blog about this here , which includes a link to the recording).
FDA Law Blog: Biosimilars
DECEMBER 6, 2024
CBERs approach here was to take FAQs from across sponsor interactions, public workshops, email requests, etc. The draft guidance includes FAQs covering topics from across disciplines: regulatory review; chemistry, manufacturing, and controls (CMC); nonclinical and pharmacology/toxicology (PT); clinical; and clinical pharmacology.
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