FDA announces new initiative for rare diseases Positive Alzheimer's trial data, workforce reductions, mRNA cancer therapy updates, and more led the news this week. Brought to you byDDN editorial team

FDA announces new initiative for rare diseases Positive Alzheimer's trial data, workforce reductions, mRNA cancer therapy updates, and more led the news this week. Brought to you byDDN editorial team https://www.drugdiscoverynews.com/fda-announces-new-initiative-for-rare-diseases-17591?utm_campaign=DDN_Newsletter_Dose&utm_medium=email&_hsenc=p2ANqtz-_0WsEXv4_HPLhEO2oRpsUuhBRW69o_BGqi7g3XEGAZaBNoMYKGclt4cnQWrnVNKcn0thGX7v7yN2hY2yoXu7HDEbodVw&_hsmi=444660716&utm_content=444660716&utm_source=hs_email The FDA has unveiled a new Rare Disease Framework Initiative designed to “reimagine the development of drugs and biologics for rare diseases,” according to the press release. Recognizing that only five percent of rare diseases having an FDA-approved treatment, the announcement describes how the new initiative seeks to include patients’ voices, build shared resources on rare disease drug development and review, and champion the use of cutting-edge science, among other commitments. As outlined in the new white paper accompanying the framework, “The goal is a regulatory framework where fit-for-purpose evidentiary expectations are the norm for all rare disease applications; the FDA will work closely with sponsors and patients to support innovative approaches to generating evidence that will meet the FDA’s rigorous statutory standard of safety and effectiveness.” – Allison Whitten