Uncategorized
FDA issues draft guidance on nonproprietary naming of biologics, biosimilars
The FDA today announced the availability of a draft guidance describing its proposal on the nonproprietary naming of biological products.According to an FDA blog post by Janet Woodcock, MD, director of FDA’s Center for Drug Evaluation and Research, and Karen Midthun, MD, director of FDA’s Center for Biologics Evaluation and Research, the nonproprietary naming of biological products is a key issue for ensuring their safety and promoting their acceptance.