Zdrowie i gospodarka · 16.08.2004
Scientific Considerations Related to Developing Follow-On Protein Products
The Food and Drug Administration (FDA) is announcing a public workshop on scientific and technical considerations related to the development of follow-on protein pharmaceutical products. The agency is planning to develop draft guidance on this topic during the coming year. The purpose of this workshop is to obtain input from interested persons on the topics outlined in this document related to developing and approving follow-on protein pharmaceutical products. The agency will consider presentations made at the workshop and comments submitted to the docket before and after the workshop when developing the draft guidance.