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# 4 New CBER Standard Policies and Procedures
- URL: https://www.fdaweb.com/4-new-cber-standard-policies-and-procedures/
- Published: 2023-02-28T12:00:00.000Z
- Updated: 2026-09-14T18:17:36.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5153863

CBER issued four new Standard Operating Policy and Procedure (SOPP) documents on 2/27:

SOPP 8421: Complying with Requirements Under the Pediatric Research Equity Act (PREA) is a first-line resource for product offices and review divisions to ensure that sponsors/applicants and CBER staff are following the required procedures and timeframes under the act. The [document](http://www.fda.gov/media/160734/download?ref=fdaweb.com) applies to INDs, NDAs, BLAs, and related NDA and BLA supplements for a new active ingredient, new indication, new dosage form, new dosing regimen, or new route of administration. It is specific to PREA and does not discuss other pediatric regulatory issues.

SOPP 8422: Processing and Review of Trans-BLA Submissions covers for Center staff the administrative procedures for the receipt and review of trans-BLAs — multiple submissions to approved BLAs that contain an identical change or changes as a single submission. The [document](http://www.fda.gov/media/80263/download?ref=fdaweb.com) stresses that the change or changes must be identical and affect multiple approved marketing applications.

SOPP 8426: Assignment of Biological and Drug Product Proper Names and Biological Suffixes covers proper names for biological products and drugs and the FDA-designated suffix applicable to each originator biological product, related biological product, and biosimilar product. [The document](http://www.fda.gov/media/96219/download?ref=fdaweb.com) describes the process for naming biological and drug products that are regulated by CBER.

Finally, SOPP 8413: Postmarketing Requirement/Commitment Related Submissions — Administrative Handling, Review, and CBER Reporting gives guidance for Center staff to administratively process, review submissions, and report on postmarketing requirements and postmarketing commitments received in CBER for BLAs and NDAs. The [document](http://www.fda.gov/media/108918/download?ref=fdaweb.com) applies to all postmarketing requirements and commitments for licensed biologics (including devices approved under a BLA) and drugs approved under an NDA that are regulated by CBER.