Cette traduction est en cours de préparation. En attendant, nous affichons temporairement la version originale en anglais.
Entreprise · 23/04/20141 min de lecture
Guidance for Industry on Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations; Availability
Traduction automatique locale · Langue originale de la source
Résumé
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations." The purpose of this guidance is to provide sponsors and manufacturers FDA's current thinking on the criteria by which two monoclonal antibody products would be considered the same under the Orphan Drug Act and implementing regulations.
Langue originale de la source: Federal Register — Food and Drug AdministrationOuvrir le communiqué original →