Biologics


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Special Events

Vendor Presentations

TERMINOLOGY UPDATE(S):


[13-Mar 2009]


Additional units of measure [http://www.fda.gov/oc/datacouncil/splncicodes.html#potency] 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:
  • Vaccines: many of the currently approved vaccines have active ingredients already available in UNII list
  • Active ingredients for plasma derivatives:
    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.
  • Immune Globulins, Allergenic Extracts: FDA is currently developing a list of relevant characteristics to be included in the SRS

Questions and Answers



SUBTEAM DETAILS


Next meeting: April 2010 [11- 12 EDT]

Minutes



Meeting Date
Minutes
March 25, 2010

May 28, 2009

March 19, 2009

January 22, 2009

August 21, 2008

Sept 25, 2008

Nov 17, 2008