As mentioned on our Health Industry Washington Watch blog, the U.S. Food and Drug Administration (FDA) has announced a plan intended to incentivize manufacturers to voluntarily update their prescription drug and biologics labels. The plan calls for the use of a government contractor to assist manufacturers in making these updates according to the labeling guidelines set forth by the Physician Labeling Rule (PLR), enacted in January 2006. As the PLR format was mandatory for drugs and biologics approved after June 30, 2001, FDA has specifically designed this plan to encourage labeling updates to drugs and biologics approved before that date. The government contractor would provide manufacturers with PLR conversion resources and support, including preparation of draft PLR format labeling.
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This article is presented for informational purposes only and is not intended to constitute legal advice.