Submission Type: Original Application Submission ID: 125296/0 Office: OVRR
Adenovirus Vaccine Live Oral Type 4 and Type 7
Duramed Research Inc.
Telecon Date/Time: 27-MAY-2009 12:00 AM Initiated by FDA? Yes
Telephone Number: 610-747-2664
Author: DARLENE HITHE
Requested detailed plan of post-marketing safety reporting to FDA per 21 CFR 800-60 for all post-marketing studies.
FDA Participants: Darlene Hithe
Non-FDA Participants: John Pakulski
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
Sponsor was contacted via telephone and asked to submit a detailed plan of post-marketing safety reporting to FDA per 21 CFR 800.60, for each of the three post-marketing studies (i.e. Sentinel Surveillance Plan, viral shedding evaluation using the Naval Health Research Center Febrile Respiratory Surveillance Program, and the Pregnancy Registry. Reference is made to email date 5/15/2009 from the Sponsor in which the Sponsor requested advice on how changes to their safety reporting plan should be reported to the BLA. The Sponsor has requested that periodic safety reports be prepared according to 21 CFR 80.60 rather than PSUR per ICH E2C guidelines.
The Sponsor acknowledged that the requested plan would be submitted to the BLA as an amendment.