Biologics

=Biologics=

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__Special Events__

Vendor Presentations

TERMINOLOGY UPDATE(S):
[13-Mar 2009]

Additional units of measure have been added: ALLERGY UNITS [AU] BIOEQUIVALENT ALLERGY UNITS [BAU] PROTEIN NITROGEN UNITS [PNU]

[01-Sept-2008] Details on how FDA analyzes Active Ingredients for UNII registration: > http://www.fda.gov/oc/datacouncil/1_11_2007SRS_Users_Guide_5B.pdf Chapter 26: Proteins and Peptides > contains a majority of the relevant characteristics.
 * Vaccines: many of the currently approved vaccines have active ingredients already available in [|UNII] list
 * Active ingredients for plasma derivatives:
 * Immune Globulins, Allergenic Extracts: FDA is currently developing a list of relevant characteristics to be included in the SRS

**SUBTEAM DETAILS**

 * Next meeting: April 2010 [11- 12 EDT] **

Minutes

 * Meeting Date || Minutes ||
 * March 25, 2010 || [[file:BiologicsSubTeam-March2010-Minutes.pdf]] ||
 * May 28, 2009 || [[file:BiologicsSubTeam-May2009-Minutes.pdf]] ||
 * March 19, 2009 || [[file:BiologicsSubTeam-Mar2009-Minutes.pdf]] ||
 * January 22, 2009 || [[file:BiologicsSubTeam-Jan2009-Minutes.pdf]] ||
 * August 21, 2008 || [[file:BiologicsSubTeam-Aug2008-Minutes.pdf]] ||
 * Sept 25, 2008 || [[file:BiologicsSubTeam-Sept2008-Minutes.pdf]] ||
 * Nov 17, 2008 || [[file:BiologicsSubTeam-Nov2008-Minutes.pdf]] ||