FDA Issues Recommendations for the Development of Individualized Therapies for Patients With Ultra-Rare Diseases

As discussed previously (“New FDA Guidance Allows Biosimilar Applicants to Use Data From Outside the U.S. To Accelerate Their Approval in the U.S.”), the U.S. Food and Drug Administration (FDA) is embracing regulatory flexibility in order to accelerate approval of biologic and biosimilar treatments. Provided here is a further discussion of the draft...... By: Knobbe Martens