Archived Content

The content on this page is provided for reference purposes only. This content has not been altered or updated since it was archived.

Vaccines, Blood & Biologics

Telecon with Fresenius Kabi - 11/28/2007 - Voluven

Telecon with Fresenius Kabi

RE: BN070012

Meeting called by: Franklin. Stephenson/ RPM

Type of meeting: Telecon 919-881-9900

FDA Participants: Franklin Stephenson, Dr. Lawrence Landow

Baxter Participants: Mr. Coln,


Conversation Record:

  • We contacted Mr. Coln and indicated to him that we had found additional errors in the PI Fresenius Kabi submitted on 27-Nov-07.
  • Dr. Landow enumerated the errors and requested additional minor comments to PI.
  • Mr. Coln said that he would communicate the corrections and will submit a non annotated version and clean a version by next week.
  • Dr. Landow inquired as to the proposed wording of the Post-Marketing Commitment that Fresenius was supposed to submit.
  • Mr. Coln indicated that they will be submitting that information as well.

Franklin T. Stephenson
Regulatory Project Manager

Page Last Updated: 02/21/2017
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English