Sunday, 1 September 2019

Guidance Documents CBER is Planning to Publish During Calendar Year 2019


In terms of what FDA CDER is planning to publish for the remainder of 2019, we can expect:

CATEGORY – Blood and Blood Components:

  • Implementation of Pathogen Reduction Technology in the Manufacture of Blood Components in Blood Establishments:  Questions and Answers; Guidance for Industry 
  • Revised Preventive Measures to Reduce the Possible Risk of Transmission of CreutzfeldtJakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products; Draft Guidance for Industry 
  • Further Testing of Donations that are Reactive on a Licensed Donor Screening Test for Antibodies to Hepatitis C Virus; Guidance for Industry 
  • Use of Serological Tests to Reduce the Risk of Transfusion Transmitted Human TLymphotropic Virus Types I and II (HTLV-I/II)1, Guidance for Industry  
  • Considerations for the Development of Dried Plasma Products Intended for Transfusion; Guidance for Industry 
  • Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Guidance for Industry
  • Recommendations for Reducing the Risk of Transfusion-Transmitted Babesiosis; Guidance for Industry (Issued May 2019)
  • Testing for Biotin Interference in In Vitro Diagnostic Devices; Draft Guidance for Industry (Issued June 2019)
CATEGORY – Tissues and Advanced Therapies:
  • Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-Up; Guidance for Industry
  • Long Term Follow-Up After Administration of Human Gene Therapy Products; Guidance for Industry 
  • Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications; Guidance for Industry 
  • Human Gene Therapy for Hemophilia; Guidance for Industry 
  • Human Gene Therapy for Retinal Disorders; Guidance for Industry 
  • Human Gene Therapy for Rare Diseases; Guidance for Industry 
  • Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations; Draft Guidance for Industry
  • Expedited Programs for Regenerative Medicine Therapies for Serious Conditions; Guidance for Industry (Issued February 2019)
  • Evaluation of Devices used with Regenerative Medicine Advanced Therapies; Guidance for Industry (Issued February 2019)
  • Standards Development and their Use in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research; Guidance for Industry and Food and Drug Administration Staff (Issued March 2019)
CATEGORY – Other
  • Interacting with the FDA on Complex and Innovative Clinical Trial Designs for Drugs and Biological Products; Draft Guidance for Industry
  • Revised Recommendations for Biological Product Deviation Reporting for Blood and Plasma Establishments; Guidance for Industry


See: https://www.fda.gov/vaccines-blood-biologics/biologics-guidances/guidance-agenda-guidance-documents-cber-planning-publish-during-calendar-year-2019

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

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