Zdrowie i gospodarka · 16/02/2005

Scientific Considerations Related to Developing Follow-On Protein Products; Reopening of Comment Period

The Food and Drug Administration (FDA) is reopening until March 16, 2005, the comment period for the notice that appeared in the Federal Register of August 16, 2004 (69 FR 50386). In the notice, FDA announced a public workshop on scientific and technical considerations related to the development of follow-on protein pharmaceutical products and plans to develop draft guidance and requested comments related to developing and approving follow-on protein pharmaceutical products. The agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.