What’s New for Biologics

What’s New for Biologics

• June 19, 2018 Summary Basis for Regulatory Action - ALBUMINEX (PDF - 140KB)
  Posted: 7/11/2018
• Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs); Draft Guidance for Industry (PDF - 486KB)
  Posted: 7/11/2018
• Long Term Follow-up After Administration of Human Gene Therapy Products; Draft Guidance for Industry (PDF - 294KB)
  Posted: 7/11/2018
• Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Draft Guidance for Industry (PDF - 124KB)
  Posted: 7/11/2018
• Human Gene Therapy for Hemophilia; Draft Guidance for Industry (PDF - 371KB)
  Posted: 7/11/2018
• Human Gene Therapy for Rare Diseases; Draft Guidance for Industry (PDF - 136KB)
  Posted: 7/11/2018
• Human Gene Therapy for Retinal Disorders; Draft Guidance for Industry (PDF - 172KB)
  Posted: 7/11/2018