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.