June 22, 2016

FDA Withdraws Biosimilars Information Collection Request from OIRA

From: Regulatory Affairs Professional Society

FDA Withdraws Document Calling on Biosimilar Developers to Submit 10 Random Suffixes

By Zachary Brennan

The US Food and Drug Administration (FDA) on Tuesday withdrew a document submitted to the Office of Management and Budget (OMB) that offered new details on how biosimilar developers would submit an ordered list of 10 random suffixes as part of the naming process for biologics and biosimilars.


Other comments on the draft guidance, according to the document submitted to OMB, suggested a higher burden related to coming up with the proposed non-proprietary names so FDA revised its “estimate upward to account for burden associated with creating and submitting up to 10 proposed suffixes for designation.”

Read Complete Article

No Comments »

No comments yet.

Leave a Reply

Name not required for anonymous comments. Email is optional and will not be published.