Regulatory News - North America
Watchdog Committee Announcements
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October 22. 2009 |
The North American Legal and Regulatory Affairs Committee of North America would like to call to the attention of our membership two Guidance Documents published in the Federal Register by the U.S. Food and Drug Administration on October 20, 2009. Both documents are related to the use of unrelated umbilical cord blood intended for hematopoietic reconstitution.
FDA final Guidance Document: Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specific Indications (October 2009).
FDA Draft Guidance Document: Investigational New Drug Applications (INDs) for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications (October 2009).
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October 6.2009 |
The document, Considerations for Allogeneic Pancreatic Islet Cell Products, provides the FDA’s recommendations to manufacturers, sponsors and clinical investigators involved in the clinical studies of allogeneic pancreatic islet cell products for the treatment of Type 1 diabetes mellitus. The entire document can be found here: http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceCompliance
RegulatoryInformation/Guidances/CellularandGeneTherapy/UCM182441.pdf
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August 9.2009 |
The following new documents/announcements have been posted to the Food and Drug Administration web site. These documents are not exclusively related to HCT/Ps but may be of interest to institutions involved in Investigational New Drug Applications (INDs) where cost recovery is applicable or if you are an institution that may enroll research subjects that that do not meet enrollment criteria of an IND.
Charging for Investigational Drugs Under an Investigation New Drug Application: http://edocket.access.gpo.gov/2009/pdf/E9-19004.pdf
Expanded Access to Investigational Drugs for Treatment Use:
http://edocket.access.gpo.gov/2009/pdf/E9-19005.pdf
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March 27.2009 |
On March 26, 2009 the FDA announced the release of a Draft Guidance Document, Use of Serological Tests to Reduce the Risk of Transmission of Trypanasoma cruzi Infection in Whole Blood and Blood Components for Transfusion and Human Cells, Tissues, and Cellular and Tissue-Based Products http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2009-D-0137-gdl.pdf.
This guidance applies to establishments that make donor eligibility determinations for HCT/P donors. According to the FDA draft document “we are notifying you that we have determined T. cruzi to be a relevant communicable disease agent under 21 CFR 1271.3(r)(2), and are providing you with recommendations for testing and screening donors for antibodies to T. cruzi”.
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February 9.2009 |
In January 2009 the FDA announced the release of a Draft Guidance Document, Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). (http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-D-0659-gdl.pdf)
This guidance applies to establishments that manufacture human cells, tissues, and cellular and tissue-based products (HCT/Ps) with recommendations for complying with Current Good Tissue Practice (CGTP) requirements. This guidance also addresses whether the establishment registration and HCT/P listing requirements apply in certain instances.
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February 9.2009 |
In November, 2008 the FDA announced the release of a Draft Guidance Document, Process Validation: General Principles and Practices (http://www.fda.gov/cvm/Guidance/guide196.pdf ).
According to the FDA Introduction of this document; this guidance outlines the general principles and approaches that FDA considers to be appropriate elements of process validation for the manufacture of biological products. This guidance incorporates principles and approaches that all manufacturers can use in validating a manufacturing process and also aligns process validation activities with the product lifecycle concept and with existing FDA guidance.
