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of CreutzfeldtJakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products; Draft Guidance for Industry 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• Testing for Biotin Interference in In Vitro Diagnostic Devices; Draft Guidance for Industry (Issued June 2019)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• Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations; Draft Guidance for Industry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