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BLA 761108/S-021
Page 6

To facilitate review of your submission, we request that you submit your proposed modified REMS and other REMS-related materials in Microsoft Word format. If certain documents, such as enrollment forms, or website screenshots are only in PDF format, they may be submitted as such, but Word format is preferred.

SUBMISSION OF REMS DOCUMENT IN SPL FORMAT

FDA can accept the REMS document in Structured Product Labeling (SPL) format. If you intend to submit the REMS document in SPL format, as soon as possible, but no later than 14 days from the date of this letter, submit the REMS document in SPL format using the FDA automated drug registration and listing system (eLIST).

For more information on submitting REMS in SPL format, please email FDAREMSwebsite@fda.hhs.gov.

PROMOTIONAL MATERIALS

You may request advisory comments on proposed introductory advertising and promotional labeling. For information about submitting promotional materials, see the final guidance for industry Providing Regulatory Submissions in Electronic and Non-Electronic Format—Promotional Labeling and Advertising Materials for Human Prescription Drugs.^[1]

As required under 21 CFR 601.12(f)(4), you must submit final promotional materials, and the Prescribing Information, at the time of initial dissemination or publication, accompanied by a Form FDA 2253. Form FDA 2253 is available at FDA.gov.^[2] Information and Instructions for completing the form can be found at FDA.gov.^[3]

REPORTING REQUIREMENTS

We remind you that you must comply with reporting requirements for an approved BLA (in 21 CFR 600.80 and in 21 CFR 600.81).

If you have any questions, contact Caden Brennen, Regulatory Project Manager, at 301-796-6591 or at Caden.Brennen@fda.hhs.gov.

Sincerely, {See appended electronic signature page}

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1. For the most recent version of a guidance, check the FDA guidance web page at https://www.fda.gov/media/128163/download.
2. http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf
3. http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf

U.S. Food and Drug Administration
Silver Spring, MD 20993
www.fda.gov

Reference ID: 5019210