tag:blogger.com,1999:blog-5251734313338196429.post1725471740827518495..comments2024-02-27T04:00:13.116-08:00Comments on Cell Therapy Blog: What's in a Name? The FDA's Got Yours.Lee Bucklerhttp://www.blogger.com/profile/05830444908952419444noreply@blogger.comBlogger3125tag:blogger.com,1999:blog-5251734313338196429.post-87735742570677050702008-11-26T12:25:00.000-08:002008-11-26T12:25:00.000-08:00FDA has also just published SOPP 8001.4 - Manual o...FDA has also just published SOPP 8001.4 - Manual of Standard Operating Procedures and Policies<BR/>General Information - Review of CBER Regulated Product Proprietary Names, Version #2, dated November 24, 2008. <BR/><BR/>http://www.fda.gov/cber/regsopp/80014.htm<BR/><BR/>"This document describes the policies, procedures, and performance goals used in the Center for Biologics Evaluation and Research (CBER) in the Food and Drug Administration (FDA) for the review and evaluation of proposed proprietary names for biological products. These procedures are intended to ensure that the requirements set forth for proprietary name reviews under the Prescription Drug User Fee Act (PDUFA IV) in the Food and Drug Administration Amendments Act of 2007 (FDAAA) are met.<BR/><BR/>For products not covered by PDUFA, the procedures set forth in this document will be used; however, the performance goals will not apply. CBER will make every effort to respond to proprietary name reviews of non-PDUFA products as expeditiously as possible."Lee Bucklerhttps://www.blogger.com/profile/05830444908952419444noreply@blogger.comtag:blogger.com,1999:blog-5251734313338196429.post-23219596600107329142008-11-24T19:00:00.000-08:002008-11-24T19:00:00.000-08:00Alexey,Look at the very bottom of the pagehttp://w...Alexey,<BR/><BR/>Look at the very bottom of the page<BR/><A>http://www.celltherapysociety.org/Meetings/Somatic_Cell_Therapy_Symposium/Presentations.aspx</A><BR/><BR/>for the Product Nomenclature session and links to presentations by <BR/>Kimberly Benton, PhD<BR/>Darin Weber, PhD<BR/>Fran RabeLee Bucklerhttps://www.blogger.com/profile/05830444908952419444noreply@blogger.comtag:blogger.com,1999:blog-5251734313338196429.post-17812527080799478532008-11-24T18:43:00.000-08:002008-11-24T18:43:00.000-08:00thanks for link to presentations from the meeting,...thanks for link to presentations from the meeting,<BR/>didn't find anything particularly about "product nomenclature for cell therapies" in FDA draft thoAnonymousnoreply@blogger.com