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: 19-MAY-2009 12:00 AM Initiated by FDA? Yes
Telephone Number: 610-747-2664
Author: DARLENE HITHE
Fax and Telecon to request inspection items and provide PM surveillance comments.
FDA Participants: Darlene Hithe
Non-FDA Participants: John Pakulski
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
The Sponsor was contacted to convey CBER reviewer comments and to request the following which had previously sent via email, due to email delivery glitches, a follow up telecon was initiated.
1. Sponsor was reminded to submit a formal request to withdraw the ----(b)(4)---- proprietary name and to advise of their intention to proceed without a proprietary name.
2. Sponsor was advised that they do not need to amend the BLA with revised SOPs which were revised pursuant to the FDA-483 issued to BRL but that they should be aware that the commitments will be followed up by Team-Bio at the next inspection. The responses received thus far are considered to be a complete response. No further information is required.
3. Sponsor was advised that the EIR can be requested after the BLA is approved. The EIRs for the Barr and BRL inspections are considered to be a complete package and are not released until after the approval of the BLA.
4. Sponsor was advised that the target date to send them a revised Word version of the label is May 22, 2009. Labeling negotiations will proceed using Word format and the final agreed upon label will need to be submitted in Word, PDF, and SPL formats. There is also the option of submitting the SPL format at the time of registration and listing.
5. Sponsor was advised to check with their IT department regarding a possible error in their secure email system.
6. A separate fax was sent to the Sponsor with a comment to revise ICD-9 codes used in their Sentinel Surveillance Plan.