07/17/2017
https://www.congress.gov...
"Given the similarity between FDA's draft guidance and the World Health Organization's scheme on biologics qualifiers, it would be important to consult with a WHO in arriving at a global solution."
"Has FDA analyzed, No. 1, the extent to which these cost of changing names is passed on to healthcare payers and consumers?"
"There are a lot of tradeoffs in the naming convention."
"Is it possible for FDA to trace adverse events and identify the source without a unique identifier in the name?"