FDA to Approve Generics Based on Proposed Labeling

The FDA is heeding industry requests to simplify the ANDA approval process by allowing generics makers to submit proposed labeling instead of final printed labeling.

Under guidance issued last week, if the FDA determines the draft labeling complies with regulatory requirements, it will sign off on the ANDA without having to see the print version.

The policy change takes effect immediately. 

Comments on the guidance may be submitted to docket no. FDA-2015-D-3378 at www.regulations.gov. Read Ability of Draft Labeling to Support ANDA Approval at www.fdanews.com/10-15-ANDA-Labeling.pdf. — Jonathon Shacat