Tag Archives: emily winfield

FDA Report on Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS)

The U.S. Food and Drug Administration (FDA) recently published a report titled “Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS),” which summarizes stakeholder engagements completed in fiscal year 2013 and fulfills FDA’s Prescription Drug User Fee Act (PDUFA) commitment to issue a report of its findings regarding REMS standardization.

FDA Releases Guidance for Industry on ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers

The U.S. Food and Drug Administration (FDA) recently published a new Guidance for Industry, titled ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers, which provides answers to questions from public comments received on the draft Guidance for Industry on ANDAs: Stability Testing of Drug Substances and Products (“FDA stability guidance”) that was published in the Federal Register on September 25, 2012. It also incorporates comments received on the same draft, which were previously published in the Federal Register on August 27, 2013.

Click here to read this Alert, written by Duane Morris Partner Rick Ball and associate Emily Winfield.