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FDA Draft Guidance on NAT tests to reduce the risks of HBV transmission from cells and tissues

Microbiological Safety of Human Cells, Tissues, and Cellular and Tissue-Based Products: FDA published a draft guidance on the "Use of Nucleic Acid Tests to Reduce the Risk of Transmission of Hepatitis B Virus".

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FDA publishes Draft Guidance for Industry "Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products"

FDA's CBER published a Draft Guidance for Industry with recommendations and examples for "Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products Regulated Solely Under Section 361 of the Public Health Service Act and 21 CFR Part 1271".

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Guidance for Treponema pallidum Screening of donors of Human Cells and Tissues (HCT/Ps)

End of 2015, the FDA finalized their draft document and issued the Guidance for Industry "Use of Donor Screening Tests to Test Donors of Human Cells, Tissues and Cellular and Tissue-Based Products for Infection with Treponema pallidum (Syphilis)".

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FDA issues draft guidance on Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products

The US FDA published a draft guidance for Industry on Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products which is supposed to provide recommendations for applying Title 21 of the Code of Federal Regulations.

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European Pharmacopoeia - Chapter 2.6.27 Microbiological Examination of cell-based Preparations revised

The issue 27.3 of Pharmeuropa also comprises a revision of Chapter 2.6.27 "Microbial Examination of cell-based Preparations". It covers the cases where a test is not feasible according to chapter 2.6.1.

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CBER - Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products

The FDA Center for Biologics Evaluation and Research (CBER) published the Guidance for Industy "Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products".

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FDA Guidances - Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products

Establishments that manufacture human cells, tissues, and cellular and tissue-based products have to comply with a number of requirements under Title 21 of the Code of Federal Regulations Part 1271 (21 CFR Part 1271). This includes Investigating and reporting adverse reactions.

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Human Cells, Tissues or Cellular- or Tissue-based Products - Exception from the Requirements under Part 1271

The US FDA published a draft guideline on Same Surgical Procedure Exception under 21 CFR 1271.15, related to human cells, tissues or cellular or tissue-based products. Read more here.

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FDA publishes Draft Guidance for Minimal Manipulation of Human Cells, Tissues, and Cellular- and Tissue-Based Products

The FDA has published a Draft Guideline with recommendations for human cells, tissues, and cellular- and tissue-based product (HCT/P) manufacturers, healthcare providers, and FDA staff  for the criterion of minimal manipulation. Learn more.

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NAT Testing of West Nile Virus from Human Cells and Tissues

As a part of their continuous review of new data related to West Nile Virus, the FDA published a Draft Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). Read more.

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