FDA Roundup
- Today, the FDA issued draft Guidance for Industry #278, Human User Safety in New and Abbreviated New Animal Drug Applications, to clarify the current approaches and the FDA’s recommendations for Human User Safety (HUS) assessment and submission of HUS information to support the overall safety of proposed new animal drugs prior to approval.
- On Monday, the FDA published a Spotlight on CDER Science examining pharmacodynamic (PD) biomarkers in biosimilar product development. The Spotlight summarizes some research that the FDA and outside investigators have been conducting in this area.
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