Zobrazeno 1 - 1
of 1
pro vyhledávání: '"Gretchen M. Bowker"'
Autor:
Gretchen M. Bowker, Gregory C. Davis
Publikováno v:
Therapeutic Innovation & Regulatory Science. 48:367-370
In 2010 Congress established a regulatory pathway for the approval of biosimilar products in the United States. FDA has embarked on developing the implementation framework for this pathway which includes creating guidance to assist biosimilar manufac