| 2 min read
Register for free to listen to this article
Listen with Speechify
0:00
2:00
SILVER SPRING, Md.—In late June, the U.S. Food and Drug Administration (FDA) issued a proposed rule to amend its regulations on the use of master files for biological products. The proposed rule, if finalized, would allow certain applications for biological products approved under the Federal, Food, Drug, and Cosmetic Act to continue incorporating by reference information on drug substances, drug substance intermediates, or drug products contained in drug master files (DMF) after the approved applications for those products are deemed to be licenses under the Public Health Service Act (PHS Act) on March 23, 2020.
 
The proposed rule would also codify the FDA’s existing practice that an application for a biological product under the PHS Act may rely on a master file, except for information on drug substances (active pharmaceutical ingredient, or API), drug substance intermediates (a material produced during steps of the processing of an API that undergoes further molecular change or purification before it becomes an API), or drug products (finished dosage forms, such as tablets or capsules).
 
In addition, the proposed rule would codify the FDA’s existing practice that information from a master file, including drug substance, drug substance intermediate or drug product information, may be relied on at the investigational phase of development for a product subject to licensure under the PHS Act.
 
Some of the applications (approximately 17, such as reproductive hormones and enzymes) that will be transitioned currently incorporate reference information contained in DMFs to support their application and were approved by the FDA based in part on the drug substance, drug substance intermediate or drug product information contained in those DMFs.
 
As the FDA says, “Many of these products have been marketed for decades and over this period, none of these products have been withdrawn or removed from the market for reasons of safety or effectiveness. For these products, the FDA has no reason to believe that the March 23, 2020, transition in and of itself introduces new risks to product safety, purity and potency.”
 
Additionally, after the transition, a proposed biosimilar and/or interchangeable product to one of these transitioned biologics may not reference the DMF for the drug substances, drug substance intermediates or drug products information, consistent with existing practice for biological products submitted in Biologics License Applications and the use of master files.

Related Topics

Published In

Volume 15 - Issue 7 | July 2019

July 2019

July 2019 Issue

Loading Next Article...
Loading Next Article...
Subscribe to Newsletter

Subscribe to our eNewsletters

Stay connected with all of the latest from Drug Discovery News.

Subscribe

Sponsored

Reliable fluid biomarkers strategies for clinical neuroscience research

Reliable fluid biomarkers strategies for clinical neuroscience research

Explore how validated fluid biomarker assays advance clinical research for neurological diseases.
A group of blue capsules is scattered on a bright yellow surface, with one capsule opened to reveal white powder inside.

Understanding drug impurities: types, sources, and analytical strategies

Unseen and often unexpected, drug impurities can slip in at every drug development stage, making their detection and control essential.
Laboratorian with a white coat and blue gloves pipettes green liquid into a beaker with multicolored liquids in beakers and tubes in the blue-tinged, sterile laboratory background.

Discovering cutting-edge nitrosamine analysis in pharmaceuticals

New tools help researchers detect and manage harmful nitrosamine impurities in drugs such as monoclonal antibodies.
Drug Discovery News March 2025 Issue
Latest IssueVolume 21 • Issue 1 • March 2025

March 2025

March 2025 Issue

Explore this issue