• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

  • Print
  • Share
  • E-mail

Section Contents Menu

Vaccines

Record of Telephone Con., January 26, 2011 - Adenovirus 

Submission Type: BLA Submission ID: 125296/0 Office: OVRR

Product: Adenovirus Vaccine Live Oral Type 4 and Type 7

Applicant: Teva Women's Health, Inc.

Telecon Date/Time: 26-Jan-2011 04:07 PM Initiated by FDA? Yes

Communication Category: Information Request

Author: Helen Gemignani

Telecon Summary: Request for Categorical Exclusion

FDAParticipants: Helen Gemignani

Non-FDA Participants: Valerie Mulligan

Telecon Body: Please submit a formal request for Categorical Exclusion from an Environmental Assessment (in Section 1.12.14 Environmental Analysis) for your product under 21 CFR 25.31.