TELEPHONE CONFERENCE MEMORANDUM
|STN 125254/0:||CTD BLA for Influenza Virus Vaccine|
|PRODUCT:||Influenza Virus Vaccine|
|DATE:||August 9, 2007|
This call was conducted to clarify and discuss CBER's interpretation of 'due diligence' in conducting postmarketing studies under an accelerated approval. Items discussed and agreements reached are listed below.
- CSL clarified their post-licensure marketing studies timeline and articulated their commitment to submit to CBER a draft protocol (detailed synopsis) of their culture confirmation study by August 31, 2007 to both the BLA as well as the IND. CSL confirmed their plans to initiate a culture confirmation study in the 2008 influenza season in the Southern Hemisphere. CSL requested CBER to provide a timely review and response to allow CSL to meet their internal timelines. CBER agreed to this request.
- CBER discussed the context of the accelerated approval regulations and that, in general, the post marketing studies in a clinical development program should be open to enrollment at the time of approval of a vaccine reviewed under an accelerated approval process. As referenced in the CBER comments to CSL dated July 31, 2007, where CBER referenced 21 CFR 601.41, "Postmarketing studies would usually be studies already underway. When required to be conducted, such studies must also be adequate and well-controlled. The applicant shall carry out any such studies with due diligence." CBER recognized that influenza virus vaccine studies are limited by seasonal constraints. As such, we noted CSL's verbalization of their desire and commitment to proceed with due diligence.
- CSL articulated their concern of how lack of circulating virus would adversely affect their study. CBER recognized this un-controlled limitation of culture-confirmation influenza vaccine studies.
- CBER agreed to the timelines of both the "at risk" adult study and the pediatric studies presented in the CSL table.
- CSL asked for clarification on whether the pediatric studies are viewed as meeting 'accelerated approval' or as a PREA requirement. CBER stated that the studies listed in the CSL table (including the pediatric study) are viewed as a comprehensive application package and not as separate development plan.
- CSL asked for clarification on the language of the postmarketing commitments and how they would be listed in the approval letter and whether CSL would have input to this effect. CBER clarified that CBER would provide comments to CSL on the submitted postmarketing draft study protocols (detailed synopsis). CSL would follow-up with a final postmarketing commitment plan submitted to the BLA which CBER would then incorporate into the approval letter.