MedDRA MSSO Comments on the Proposed Safety Rule (Docket No. 00N-1484)From: Patrick.Revelle@ngc.com Sent: Monday, October 13, 2003 4:14 PM To: FDADockets@oc.fda.gov Subject: MedDRA MSSO Comments on the Proposed Safety Rule (Docket No. 00N-1484) Dear FDA, The attached are two sets of comments on the Proposed Rule - Safety Reporting Requirements for Human Drug and Biological Products (Docket No. 00N-1484). The first comments (MSSO Comments on Safety Reporting Requirements.doc) are a set of comments from the MedDRA Maintenance and Support Services Organization (MSSO). The comments expressed in this document reflect the opinions of the MedDRA Maintenance and Support Services Organization (MSSO) and are not necessarily those of the MedDRA Management Board. The second document (MedDRA 62 Annex 4 - MB endorsed Position Oct 10.doc) is a document submitted by the MSSO and is endorsed by the ICH MedDRA Management Board. Best regards, Pat Pat Revelle Director, MSSO Products & Services Northrop Grumman 12011 Sunset Hills Road Reston, Virginia 20190-3285 USA Voice : 703.345.7722 Fax : 703.345.7791 Email : patrick.revelle@ngc.com Website : www.meddramsso.com <> <>