02/25/2015
https://www.congress.gov...
"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."
"Do we need to legislate that people have a common API?"
"The taxpayer didn't finance this to create another business model for a provider of information."
"I agree with you all so much that it's a little bit hard for me to formulate a question, because there's nothing to challenge."