At RAPS Convergence 2026 in Charlotte, Jennifer Albert, a regulatory project manager and regulatory scientific reviewer at FDA, shared her advice for sponsors preparing BLAs for CBER’s Office of Therapeutic Products (OTP).
RAPS covered the session, and the advice is worth reading in full.
None of it should strike anyone as particularly surprising or novel. We’d characterize it more as the kind of guidance that’s easy to agree with and easy to underexecute. So for each tip below, we’ve summarized what Albert said as RAPS reported it, then added some additional practical advice from our own BLA support work.
1. Run everything through the RPM
Jennifer noted that the regulatory project manager is the applicant’s single point of contact for everything related to the BLA, including clinical and regulatory questions, and coordinates the submission across all six OTP offices.
She added that applicants should always use secure FDA email, put the BLA number in every amendment subject line, and clearly mark urgent communications. Individual reviewers should not be contacted during a review. And as a courtesy, applicants should give the RPM a heads-up before submitting an amendment.
We’d take this advice a step further by setting up secure email well before you need it. CBER sends regulatory communications to sponsors by secure email, and its policy requests to establish it go to SecureEmail@fda.hhs.gov. That setup might take time, and you need a non-ISP email domain to do it. Don’t let your first urgent information request get delayed because secure email hasn’t been established yet!
Another tip here is to try and “mirror” the RPM on your side, too. Name one person who owns all FDA communication for the BLA, and keep a running log of every exchange: date, subject, what was asked, what was committed to. When you pre-notify the RPM about an amendment, keep it short and useful: what’s coming, why, and which module it touches.
2. Take the end-of-phase 2 and pre-BLA meetings, and build against the official record
Jennifer encouraged sponsors to request end-of-phase 2 and pre-BLA meetings even when they aren't required, saying there's no disadvantage to having them.
End-of-phase 2 is the chance to confirm that the FDA agrees with your pivotal trial design before committing to phase 3. OTP grants one pre-BLA meeting per product or indication, and that meeting covers content and format, topline data, outstanding issues, and labeling concepts. Issues raised there are expected to be addressed in the BLA. She described it as a strategic checkpoint instead of a formality.
We’d add that timing matters a lot here. Hold the pre-BLA meeting when you have enough data and a settled enough application structure for FDA’s feedback to be concrete, and early enough that you have time to act on what you hear. OTP currently recommends that the pre-BLA meeting occur at least two months before the planned BLA submission, which generally means submitting the meeting request at least four months in advance.
When the FDA’s meeting summary arrives, treat it as the official record and turn it into a tracker you can use. List each agreement, recommendation, action item, or unresolved issue, who owns the response, and where in the BLA it’s addressed .That tracker becomes your internal pre-submission check, and it can also feed your reviewer's guide.
3. If you qualify for rolling review, wait for the grant letter
Jennifer noted that products with RMAT, breakthrough therapy, or fast track designation can qualify for rolling review, which lets applicants submit completed BLA modules on a rolling basis.
Rolling review comes up during the pre-BLA meeting, and the formal request can go through the associated IND. She cautioned though not to submit BLA modules until you’ve received a grant letter.
Rolling review doesn't mean sending partially finished modules. The modules you submit early should be complete and stable, even though other parts of the BLA may still be in development. We encourage teams to build a realistic module-submission schedule, discuss it at the pre-BLA meeting, submit the formal request through the IND, and not start the rolling BLA until FDA grants the request.
4. Know exactly what belongs in Module 3
Jennifer noted that the FDA doesn’t allow a BLA to reference CMC information from a Type II drug master file. It does permit some information from Type III and Type IV master files, such as packaging materials, container closures, excipients, and raw materials used in preparing the drug substance, drug substance intermediate, or drug product.