10/12/2015
https://www.congress.gov...
"You told us last year in ENC though that you had a difficult time inspecting plants in India."
"Clearly you can have a little bit of wiggle room and presumably you don't want to develop that."
"The questions are, the guidance on the statistical approaches to analytical similarity is particularly important as it impacts initial improvability as a biosimilar under the 351K."
"Thank you, Senator Hatch."