Rx REPORT

CBER Publishes their Updated 2017 Guidance Agenda

CBER recently published their updated Guidance Agenda for 2017.  The following documents have been added to this updated Guidance Agenda:

  • Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi infection in Blood and Blood Components; Guidance for Industry
  • Requalification of Donors Previously Deferred for a history of Viral Hepatitis after their 11th Birthday; Guidance for Industry
  • An Acceptable Circular of Information for the Use of Human Blood and Blood Components; Guidance for Industry
  • Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV), product Disposition, and Donor Deferral and Reentry; Guidance for Industry
  • Devices Used in the Recovery, Isolation, or Delivery of Regenerative Medicine Advanced Therapies; Draft Guidance for Industry

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