FDA Issues a Final Rule on Biologics License Applications, Investigational New Drug Applications and Master Files



On February 12, the FDA issued a final rule regarding the use of Drug Master Files (“DMF”) in Biologics License Applications.

DMFs are submissions to the FDA “used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products.”  Under the final rule, approved BLAs can continue to incorporate by reference information on drug substances, drug substance intermediates, and drug products (“DS/DSI/DP”) contained in DMFs, if the data were referenced at the time of the initial application’s approval.

Notably, Investigational New Drug Applications for biologics can incorporate by reference any information, including DS/DSI/DP information, contained in DMFs.  However, the rule stipulates that BLAs for combination products may only incorporate DS/DSI/DP information by reference for the non-biological constituent of the product, not the biological constituent.

According to the FDA, the final rule codifies longstanding FDA practice and will “avoid unnecessary disruptions and potential drug shortages for these products.”  Ultimately, the FDA predicts that the rule will provide advantages in administrative efficiency and predictability.

The final rule goes into effect on March 13, 2024.

[View source.]

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Goodwin | Attorney Advertising

Written by:


Goodwin on:

Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
- hide
- hide