Zdrowie i gospodarka · 18/08/2003
FDA Releases Draft Guidance for Chemistry, Manufacturing, and Control Reviewers of Human Somatic Cell Therapy INDs
The FDA has made available a draft document outlining instructions and a template for reviewers of human somatic cell therapy Investigational New Drug Applications (INDs) to assess and record relevant information, aiming to finalize the guidance by an unspecified date.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →