Drug Labelling

FDA Aims to Help Drugmakers Update Labeling Format

The FDA is seeking stakeholder feedback on a proposed initiative that would encourage drugmakers to use an updated drug labeling format even if they are not legally required to do so. The Prescription Drug Labeling Improvement and Enhancement Initiative and an associated pilot project would ask applicants with NDAs, BLAs or efficacy supplements (ESs) approved before June 30, 2001, and ANDAs for which the reference drug has been withdrawn for reasons other than safety or effectiveness to voluntarily convert their labeling to the “Physician Labeling Rule” (PLR) format and submit it for approval. The FDA intends to identify and prioritize certain drugs and drug classes for label conversion based on public health impact.

Washington Drug Letter

Reference:

http://www.fdanews.com/newsletter/article?issueId=16575&articleId=153378