Date: October 14, 2009
To: The File
From: Division of Vaccines and Related Products Applications
Office of Vaccines Research and Review
Point of Contact: LT Elizabeth J. Valenti, REHS
Regulatory Program Manager
Subject: Monthly Meeting, STN: 125300
Weekly reports for Dr. Baylor
Every week, Dr. Baylor now wants an update on every review of every BLA. He will send out a template for the Chair to follow. This should be sent to Valerie Marshall – Dr. Baylor’s special assistant through the Team Leaders, as necessary, The Chair and RPM’s chiefs and Division Directors, and Wellington Sun.
Posting of BLA review communications to the web
Almost all of the communications that have been uploaded to the EDR will be posted to the web, once approved. This includes internal emails. Please make sure all uploaded material is suitable for web posting and the individuals included on the communications are aware of this.
The review team was reminded to attach Word versions to their reviews and communications prior to loading them in the EDR.
Timeline of CR review
Please refer to milestone table in the agenda, but all reviews should be finalized and signed off by the end of December.
The first labeling meeting has already been sent out (November 4) but will be rescheduled for two weeks later to give everyone time to review the label.
- Clinical – Margaret Bash – Pieces of the original application are in the review but the remainder and the CR response needs to be finalized. There is a question of sera testing. This is not thought to affect the non-inferiority of the clinical trials. But the clinical review has not been finished yet.
- Statistical – Barbara Krasnicka – The statistical analyses have not been re-run, but Novartis supplied CBER with the information requested. The review of the original submission is completed and this review will be completed by about the end of October.
- BIMO – review completed.
- DPQ – Rajesh Gupta – The sponsor has provided all the validation CBER asked for but it has not been reviewed. Will have review finished by the end of December. The lot release protocol is not finished and CBER is accepting Novartis’ proposal in A016 for pre-licensure testing. CBER has now agreed that Novartis can sell this previously manufactured lot. CBER needs the samples from Novartis ASAP.
- CMC– Robert Lee – not present.
- CMC – Daron Freedberg – has not looked at the CMC response yet, but review of original submission is finished in draft format.
- DMPQ – Review of Line 3 CP information is not complete. No issues to date. Comments made regarding #32 in the CR in reference to the need for toxicology review related to extractable study (see below).
- Labeling – Willie Vann/Cara Fiore – APLB review completed of labeling (uploaded) but has carton container comments. The proper name for the product is approved: Meningococcal Group A, C, Y, and W-135 Oligosaccharide Diphtheria CMR 197 Conjugate Vaccine.
- Toxicology – review complete (but CR question #32 should be reviewed incorporated. See below.)
- Reproductive Toxicology – review completed.
- Assay Validation – aP (Burns) and DT (Meysick) reviews completed. The hSBA (Blake) review is not yet complete.
- OBE/PMC – Cara Fiore – CBER is waiting for the b(4) studies to come in from the sponsor (who conveyed that it would be submitted in November).
Non-proprietary name (proper) review
Willie suggested Meningococcal Group A, C, Y, and W-135 Oligosaccharide Diphtheria CRM197 Conjugate Vaccine and there were no concerns. This name will be forwarded to the sponsor and corrected in RMS-BLA.
The procedure for getting the product’s UNII code has been identified. The active and inactive ingredients list needs to be confirmed by the product reviewers and then Betsy Valenti will request the UNII code.
There was a question (#32) in the CR letter regarding methodology and the findings of extraction process of --b(4)---------------. A review team member will review the response to determine acceptability. DMPQ does not have the expertise to review this.
- C. Fiore to convey to sponsor that the previously manufactured lots can be used for both pre-licensure testing and launch, as decided by Milan Blake and Willie Vann.
- CMC and Tox to review stopper extractables.
- C. Fiore to reschedule labeling meeting.
- E. Valenti to request UNII code.
- All reviewers to have completed, signed off reviews by the end of December.
- APLB to send carton and container comments to be relayed to the sponsor.
- DPQ to communicate the need and process for samples and launch lots to the sponsor.