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Home » Industry Groups Spar Over Biogenerics in Comments to FDA
Industry Groups Spar Over Biogenerics in Comments to FDA
May 18, 2005
While PhRMA and biotechnology companies recently urged the FDA to protect the companies’ trade secrets and proceed cautiously with regards to follow-on protein products, the Generic Pharmaceutical Association (GPhA) reasserted its position that the science exists for an abbreviated approval process for biogenerics, and said additional FDA-sponsored workshops on the subject are not necessary.