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Home » Genentech Wants to Block FDA Use of Drug Data for Biogenerics Guidance
Genentech Wants to Block FDA Use of Drug Data for Biogenerics Guidance
June 1, 2006
In a citizen petition opposing FDA approval of Sandoz’ follow-on human growth hormone Omnitrope, biotechnology firm Genentech asked the agency to notify drugmakers of any potential use of their drugs’ safety and efficacy data, a move that would stymie the agency’s efforts to draft a guidance for the manufacture of follow-on biologics.