US CBER 2013: new vaccines and draft guides for biologics trials
The Center for Biologics Evaluation and Research (CBER) published its 2013 report last month, highlighting the approval of five influenza vaccines – including the cell culture produced Flucelvax and the recombinant DNA-based Flublok – as key achievements.
The organisation also approved extensions to BLAs covering Pfizer’s pneumococcal disease vaccine Prevnar 13, GSK’s Japanese encephalitis anti-infective and Novartis’ meningitis blocker Menveo, clearing each product for use in a broader range of age groups.
Other therapies approved by the agency last year include Kcentra, a treatment for warfarin-induced bleeding, and Baxter’s recombinant bleeding treatment for haemophiliacs.
Publication of the report comes a few weeks after the CBER announced that it will move to the US Food and Drug Administration’s (FDA) White Oak campus in Maryland on April 25, in a process that it said delay reviews.
“During the move, CBER will make every effort to conduct its business with minimal disruption. This includes making efforts to meet review time frames and to minimize any potential delays. Should delays affecting receipt and review of applications and other submissions occur, we intend to update this Website if needed.”
The CBER advised developers planning to file BLAs, regulatory submissions and all other correspondence through its online portal. Written requests should be sent to its current document control centre in Rockville, Maryland.
It also said “the notice of new address for regulatory submissions and other mail will be posted on this website [CBER} in early May, when the CBER Document Control Center begins moving.”
Lot release
One of the other key functions of the CBER is checking product samples to determine if they have been produced in accordance with specifications set out in the applicable BLA.
And for this function – known as lot release – the agency does not anticipate any disruption even while the relevant reviewers – the sample custodians - are moving.
“CBER will not be able to receive lot release samples during the two weeks surrounding this personnel move. This pause will allow us to assure the orderly transfer of lot release samples to the FDA White Oak campus in the weeks immediately before and after this move.
“Therefore, lot release samples should be shipped to CBER either before the pause, using the current Nicholson Lane address for CBER’s Sample Custodian, or after the pause, using the new White Oak address for the Sample Custodian once it takes effect. This pause does not involve or impact CBER’s ability to receive lot release protocols.
The agency added that it “plans to communicate directly with those manufacturers affected by this temporary interruption in CBER’s receipt of lot release samples.”
