FDA-Mandated Label Changes Guidance Gives Insight to Potential ANDA Applicants Requirements to Seek Label Changes

FDA published its final Guidance to Industry – Safety Labeling Changes – Implementation of Section 505(o)(4) of the FD&C Act on July 30, 2013. Section 505(o)(4) (enacted under the FDAAA in 2007) gave the FDA new authority to require NDA, BLA and ANDA applicants for which there is no corresponding NDA to make certain label changes if there is new information available relative to safety issues. That new safety information may impact or require a Boxed Warning, changes to the Contraindications, Adverse Event or Warnings sections of the labeling. It could also require a change to a REMS program or patient information sheet.

A Flair for the PLAIR

, what is a PLAIR? It stands for Pre-Launch Activities Importation Request. Over the last few years, the FDA had issued some informal directions in the form of an instructions sheet and a Question and Answers document. Today the contents of those documents have been incorporated into a Draft Guidance

FDA Means Business on Unapproved Drugs – If You Don’t Believe It, Just Wait and See!

At the urging of the FDA, the Department of Justice (DOJ) filed suit against Sage Pharmaceuticals of Louisiana for the marketing of unapproved new drugs. The action comes after numerous warnings and a 2000 injunction against the firm for marketing two unapproved drugs. Failure to recognize that the FDA really meant what it said landed the company and two of its officers in hot water.