What’s New for Biologics

What’s New for Biologics

• Biological Product Deviation Reporting - Blood Product Codes (PDF - 21KB)
  Updated: 9/28/2018
• Biological Product Deviation Reporting and HCT/P Deviation Reporting - Deviation Codes (PDF - 307KB)
  Updated: 9/28/2018
• Biological Product Deviation Reporting and HCT/P Deviation Reporting - Non-Blood Product Codes (PDF - 264KB)
  Updated: 9/28/2018
• Briefing Document - World Health Organization Web Links for 153rd VRBPAC Meeting - October 3, 2018
  Updated: 9/28/2018
• CBER Secure Email Policy Takes Effect October 1, 2018
  Updated: 9/28/2018
• SOPP 8117: Issuing Tracking Numbers in Advance of Electronic Submissions in eCTD Format (PDF - 101KB)
  Updated: 9/28/2018
• SOPP 8119: Use of Email for Regulatory Communications (PDF - 376KB)
  Updated: 9/28/2018