FDA Actively Releases Several Guidances for Cellular Therapy Community
Throughout the past few months, the FDA has released numerous final and draft guidances that are pertinent to cellular therapy. The following are summaries of recent documents.
Final Guidance on Testing for Treponema pallidum (Syphilis)
The FDA published updated recommendations concerning donor testing for evidence of Treponema pallidum (T. pallidum) infection, the etiologic agent of syphilis. As required under 21 CFR 1271.80(a) and (c) (§ 1271.80(a) and (c)), testing must be performed using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer’s instructions, unless an exception to this requirement applies under 21 CFR 1271.90. This guidance clarifies that the FDA does not consider cleared or approved diagnostic tests or pre-amendment devices (which have not been licensed, approved, or cleared) to be adequate for use in donor testing for T. pallidum infection under the criteria specified in § 1271.80(c).
Draft Guidance on Testing for West Nile Virus
The FDA also announced the availability of a draft document entitled “Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Draft Guidance for Industry.”
The FDA recommends the use of an FDA-licensed nucleic acid test (NAT) to test living donors of HCT/Ps for evidence of infection with West Nile Virus (WNV) to reduce the risk of transmission to recipients.
Draft Guidance on Deviation Reporting
The Food and Drug Administration announced the availability of a draft document entitled “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and Tissue-Based Products Regulated Solely Under Section 361 of the Public Health Service Act and 21 CFR part 1271; Draft Guidance for Industry.”
The draft guidance document provides certain establishments that manufacture non-reproductive human cells, tissues, and cellular and tissue-based products (HCT/Ps), regulated solely under the Public Health Service Act (PHS Act) and under FDA regulations, with recommendations and relevant examples for complying with the requirements to report HCT/P deviations.
Final Guidance on Investigating and Reporting Adverse Reactions
The FDA published finalized guidance entitled, “Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Regulated Solely Under Section 361 of the Public Health Service Act and 21 CFR part 1271; Guidance for Industry.” The guidance document provides establishments that manufacture HCT/Ps for which no premarket submissions are required with recommendations for complying with the requirements for investigating and reporting adverse reactions involving communicable disease in recipients of these HCT/Ps. The guidance also provides updated information specific to reporting adverse reactions related to HCT/Ps to supplement the general instructions accompanying the MedWatch mandatory reporting form, Form FDA 3500A.
Draft Guidance regarding Homologous Use of HCT/Ps
The FDA announced the availability of, “Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and FDA Staff.” The draft guidance document provides human cells, tissues, and cellular and tissue-based product (HCT/P) manufacturers, health care providers, and FDA staff with recommendations for applying the criterion of “homologous use” as it applies to HCT/Ps. Comments must be submitted by September 27, 2016.
Draft Guidances Reopened for Public Comment
The FDA is again accepting comments for the following draft guidance documents. Comments must be submitted by September 27, 2106.
- Human Cells, Tissues, and Cellular and Tissue-Based Products From Adipose Tissue: Regulatory Considerations; Draft Guidance for Industry
- Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and Food and Drug Administration Staff
- Same Surgical Procedure Exception: Questions and Answers Regarding the Scope of the Exception; Draft Guidance for Industry
