{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,19]],"date-time":"2026-10-19T01:30:58Z","timestamp":1792373458801,"version":"4.4.0"},"reference-count":12,"publisher":"SAGE Publications","issue":"3","license":[{"start":{"date-parts":[[2022,7,28]],"date-time":"2022-07-28T00:00:00Z","timestamp":1658966400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Appl Biosaf."],"published-print":{"date-parts":[[2022,9,1]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction:<\/jats:title>\n                    <jats:p>The US regulatory environment is evolving to accommodate a boom in gene therapy research. The 2019 version of the National Institutes of Health (NIH) Guidelines on Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) lacks an appendix providing specific guidance for Institutional Biosafety Committee (IBC) review of clinical trials.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion:<\/jats:title>\n                    <jats:p>As the field matures, the burden of Federal oversight for clinical trials of investigational products containing recombinant or synthetic nucleic acid molecules is shifting toward the Food and Drug Administration (FDA). This report summarizes recent FDA guidance documents on shedding and considerations for environmental impact assessments highlighting key points pertinent to IBC review.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>This report helps biosafety professionals understand the evolving regulatory framework for gene therapy products. Knowledge of the guidance documents discussed in this report will assist biosafety professionals in addressing issues pertaining to shedding and environmental impact during IBC review of clinical trials.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1089\/apb.2022.0020","type":"journal-article","created":{"date-parts":[[2022,7,29]],"date-time":"2022-07-29T10:55:41Z","timestamp":1659092141000},"page":"191-197","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":18,"title":["FDA Guidance on Shedding and Environmental Impact in Clinical Trials Involving Gene Therapy Products"],"prefix":"10.1177","volume":"27","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6607-4497","authenticated-orcid":false,"given":"Daniel","family":"Eisenman","sequence":"first","affiliation":[{"name":"Biosafety Services, Advarra, Inc., Columbia, Maryland, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Scott","family":"Swindle","sequence":"additional","affiliation":[{"name":"Biosafety Services, Advarra, Inc., Columbia, Maryland, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2022,7,28]]},"reference":[{"key":"e_1_3_4_2_2","doi-asserted-by":"publisher","DOI":"10.1177\/1535676019854866"},{"key":"e_1_3_4_3_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMp1810628"},{"key":"e_1_3_4_4_2","unstructured":"Points to consider: institutional biosafety committee (IBC) review of human gene transfer protocols. 2016. https:\/\/osp.od.nih.gov\/wp-content\/uploads\/PTC_from_AppendixM_042319_508.pdf. Accessed May29 2021."},{"key":"e_1_3_4_5_2","unstructured":"Cellular & Gene Therapy Guidances . Food and Drug Administration Center for Biologics Evaluation and Research. 2021. https:\/\/www.fda.gov\/vaccines-blood-biologics\/biologics-guidances\/cellular-gene-therapy-guidances. Accessed May9 2022."},{"key":"e_1_3_4_6_2","unstructured":"Guidance for Industry: Gene Therapy Clinical Trials\u2014Observing Subjects for Delayed Adverse Events FDA. 2006. www.fda.gov\/biologicsbloodvaccines\/guidancecomplianceregulatoryinformation\/guidances\/cellularandgenetherapy\/ucm072957.htm. Accessed May9 2022."},{"key":"e_1_3_4_7_2","volume-title":"Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products","author":"Food and Drug Administration","year":"2015","unstructured":"Food and Drug Administration. Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products. FDA: Silver Spring, MD; 2015."},{"key":"e_1_3_4_8_2","volume-title":"Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products","author":"Food and Drug Administration","year":"2015","unstructured":"Food and Drug Administration. Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products. FDA: Silver Spring, MD; 2015."},{"key":"e_1_3_4_9_2","unstructured":"Federal Register. Vol. 62 No. 145 pages 40570-40579. Tuesday July 29 1997. https:\/\/www.govinfo.gov\/content\/pkg\/FR-1997-07-29\/pdf\/97-19566.pdf#page=23. Accessed May9 2022."},{"key":"e_1_3_4_10_2","unstructured":"FDA Guidance for Industry: Environmental Assessment of Human Drug and Biologics Applications July 1998. www.fda.gov\/downloads\/Drugs\/GuidanceComplianceRegulatoryInformation\/Guid ances\/ucm070561.pdf. Accessed May9 2022."},{"key":"e_1_3_4_11_2","unstructured":"Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry Manufacturing and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs) April 2008. www.fda.gov\/BiologicsBloodVaccines\/GuidanceComplianceRegulatoryInformation\/Guidances\/CellularandGeneTherapy\/ucm072587.htm. Accessed May9 2022."},{"key":"e_1_3_4_12_2","doi-asserted-by":"publisher","DOI":"10.1002\/jgm.1096"},{"key":"e_1_3_4_13_2","unstructured":"ICH. ICH Harmonized Tripartite Guideline: Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials for the Conduct of Human Trials and Marketing Authorization for Pharmaceuticals M3(R2); 2009."}],"container-title":["Applied Biosafety"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1089\/apb.2022.0020","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1089\/apb.2022.0020","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1089\/apb.2022.0020","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T11:38:20Z","timestamp":1777376300000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1089\/apb.2022.0020"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,7,28]]},"references-count":12,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2022,9,1]]}},"alternative-id":["10.1089\/apb.2022.0020"],"URL":"https:\/\/doi.org\/10.1089\/apb.2022.0020","relation":{},"ISSN":["1535-6760","2470-1246"],"issn-type":[{"value":"1535-6760","type":"print"},{"value":"2470-1246","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,7,28]]}}}