دورية أكاديمية
Blood product use for radiological/nuclear trauma: product development and US regulatory considerations.
| العنوان: | Blood product use for radiological/nuclear trauma: product development and US regulatory considerations. |
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| المؤلفون: | Silverman TA; Tunnell Government Services, Bethesda, Maryland, USA.; Division of Chemical, Biological, Radiological, and Nuclear Medical Countermeasure, Biomedical Advanced Research and Development Authority, Washington, District of Columbia, USA., Shadiack AM; Tunnell Government Services, Bethesda, Maryland, USA.; Division of Chemical, Biological, Radiological, and Nuclear Medical Countermeasure, Biomedical Advanced Research and Development Authority, Washington, District of Columbia, USA., Hofmeyer KA; Biomedical Advanced Research and Development Authority, Washington, District of Columbia, USA., Cecere AE; Biomedical Advanced Research and Development Authority, Washington, District of Columbia, USA., Eisnor DL; Division of Clinical Development, Biomedical Advanced Research and Development Authority, Washington, District of Columbia, USA., Hoffman CM; Division of Chemical, Biological, Radiological, and Nuclear Medical Countermeasure, Biomedical Advanced Research and Development Authority, Washington, District of Columbia, USA., Loelius SG; Division of Chemical, Biological, Radiological, and Nuclear Medical Countermeasure, Biomedical Advanced Research and Development Authority, Washington, District of Columbia, USA., Patel A; Division of Regulatory and Quality Affairs, Biomedical Advanced Research and Development Authority, Washington, District of Columbia, USA., Homer MJ; Division of Chemical, Biological, Radiological, and Nuclear Medical Countermeasure, Biomedical Advanced Research and Development Authority, Washington, District of Columbia, USA. |
| المصدر: | Trauma surgery & acute care open [Trauma Surg Acute Care Open] 2024 Jan 05; Vol. 9 (Suppl 1), pp. e001123. Date of Electronic Publication: 2024 Jan 05 (Print Publication: 2024). |
| نوع المنشور: | Journal Article; Review |
| اللغة: | English |
| بيانات الدورية: | Publisher: BMJ Country of Publication: England NLM ID: 101698646 Publication Model: eCollection Cited Medium: Internet ISSN: 2397-5776 (Electronic) Linking ISSN: 23975776 NLM ISO Abbreviation: Trauma Surg Acute Care Open Subsets: PubMed not MEDLINE |
| أسماء مطبوعة: | Original Publication: [London] : BMJ, [2016]- |
| مستخلص: | Blood products are likely to be critical components of the medical response to nuclear detonation, as the hematopoietic subsyndrome of acute radiation syndrome (H-ARS) includes depletion of platelets and red blood cells that can lead to lethal hemorrhage and anemia. There is, however, only limited clinical information on the use of blood products to treat H-ARS. As currently configured, the US blood supply cannot meet the predicted surge in blood product demand that is likely to occur short-term and possibly long-term in the event of a large nuclear detonation. As part of the Administration for Strategic Preparedness and Response within the US Department of Health and Human Services, the Biomedical Advanced Research and Development Authority (BARDA) is addressing this preparedness gap by supporting the development of novel blood products and devices with characteristics that improve blood product storage and use in austere operational environments. The US Food and Drug Administration's Center for Drug Evaluation and Research (CDER) recently issued draft guidance on the development of drugs and biologics regulated by CDER to prevent or treat Acute Radiation Syndrome under the provisions of the "Animal Rule." The commentary provided here discusses the unique regulatory scheme for transfusion components and blood products regulated as biological drugs by Center for Biologics Evaluation and Research, including the ambiguity surrounding the evidentiary requirements for their approval for H-ARS, and whether, under certain circumstances, a specific H-ARS indication is necessary if relevant commercial indications are approved. Competing Interests: Competing interests: None declared. (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.) |
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| فهرسة مساهمة: | Keywords: biomedical research; blood; hemorrhage; policy |
| تواريخ الأحداث: | Date Created: 20240110 Latest Revision: 20240111 |
| رمز التحديث: | 20240111 |
| مُعرف محوري في PubMed: | PMC10773416 |
| DOI: | 10.1136/tsaco-2023-001123 |
| PMID: | 38196926 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 2397-5776 |
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| DOI: | 10.1136/tsaco-2023-001123 |