05/25/2010
https://www.congress.gov...
"I know that Ranking Member Wyden is committed to working with me to update and improve our understanding of this situation."
"Is it possible for FDA to trace adverse events and identify the source without a unique identifier in the name?"
"Given the similarity between FDA's draft guidance and the World Health Organization's scheme on biologics qualifiers, it would be important to consult with a WHO in arriving at a global solution."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?"