Every year CDER publishes a list of the guidance it plans to create or revise during the year. This year’s list was published in early March and it contains a number of interesting topics. Some of these we have already discussed (like “Rare Diseases: Natural History Studies for Drug Development” (see this post) and “Survey Methodologies to Assess REMS Goals Related to Knowledge” (see this post). Others look interesting, like “Comparative Analytical Assessment to Support a Demonstration of Biosimilarity to a Therapeutic Protein Product”, “Bispecific Antibody Development Programs” (currently a hot topic in discovery programs), and an update to the Pharmacogenomic Data Submission guidance issued in 2005. I’ll discuss what I’ve learned about this last topic in a future post; meanwhile, I invite you to browse the list for your favorite topics.

Text Copyright © 2019 Katrina Rogers