FDA’s Guidance Document To-Do List Grows
Since releasing its annual guidance agenda in December, FDA has added a number of guidances to its development agenda.
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House drafters’ dissatisfaction with FDA’s performance is evident in several provisions of draft user fee legislation. The agency would be required to finalize some guidances within a year of issuing a draft, which likely would provide more predictability for industry.
The agency’s first three draft guidances on biosimilar product development describe how to characterize biosimilar and reference products and extrapolate data on one condition of use to another. FDA says interchangeability is difficult to determine now and will require a switching study.
Standards were required in FDAAA; industry asked for them in part to avoid conflicts with California pedigree law that will be implemented in 2015.