المؤلفون: Donin, G., Kozik, M.

المصدر: IFMBE Proceedings (Ediția 6, Vol.92)

مصطلحات موضوعية: clinical studies, medical devices, Premarket approval, Publication practice, Regulatory process

وصف الملف: application/pdf

Relation: https://ibn.idsi.md/vizualizare_articol/189488

الاتاحة: https://ibn.idsi.md/vizualizare_articol/189488
https://doi.org/10.1007/978-3-031-42782-4_1

المؤلفون: Aashka Shah, Michelle M. Olson, Joseph M. Maurice

المصدر: Surgery in Practice and Science, Vol 12, Iss , Pp 100158- (2023)

مصطلحات موضوعية: FDA device approval, FDA device recall, 510(k) pathway, Premarket approval process, General surgery, Plastic surgery, Surgery, RD1-811

وصف الملف: electronic resource

Relation: http://www.sciencedirect.com/science/article/pii/S2666262023000049; https://doaj.org/toc/2666-2620

URL الوصول: https://doaj.org/article/ebec13a0f3f74fcabe93903251cc4c55

المؤلفون: Leire Escajedo San-Epifanio, Igor Filibi, Ainhoa Lasa López, Pere Puigdomènech, Javier Uncetabarrenechea Larrabe

المصدر: Frontiers in Plant Science, Vol 14 (2023)

مصطلحات موضوعية: European integration, EU regulatory framework for plant breeding, EU legislation on new genomic techniques, premarket approval of CRISPR-edited plants, EU status of CRISPR-edited plants, Plant culture, SB1-1110

وصف الملف: electronic resource

Relation: https://www.frontiersin.org/articles/10.3389/fpls.2023.1141455/full; https://doaj.org/toc/1664-462X

URL الوصول: https://doaj.org/article/8c56b049419e4d66a097b759d02c9666

المؤلفون: Escajedo San-Epifanio, Leire, Filibi, Igor, Lasa López, Ainhoa, Puigdomènech, Pere, Uncetabarrenechea Larrabe, Javier

مصطلحات موضوعية: European integration, EU regulatory framework for plant breeding, EU legislation on new genomic techniques, Premarket approval of CRISPR-edited plants, EU status of CRISPR-edited plants

وصف الملف: application/pdf

Relation: Agencia Estatal de Investigación PID2021-123796OB-C21; Frontiers in plant science; Vol. 14 (March 2023), art. 1141455; https://ddd.uab.cat/record/282629; urn:10.3389/fpls.2023.1141455; urn:oai:ddd.uab.cat:282629; urn:pmcid:PMC10061071; urn:pmc-uid:10061071; urn:pmid:37008488; urn:oai:pubmedcentral.nih.gov:10061071; urn:articleid:1664462Xv14p1141455

الاتاحة: https://ddd.uab.cat/record/282629

المؤلفون: Winther, Henrik, Borrebaeck, Carl

المصدر: Advances in Medical Imaging, Detection, and Diagnosis. :487-505

مصطلحات موضوعية: area under the curve (AUC), assay workflow, bioinformatics, biomarker, biopsies, cancer, China Food and Drug Administration (CFDA), circulating tumor DNA (ctDNA), clinical accuracy, cross-validation, diagnostic, enzyme-linked immunosorbent assay (ELISA), European Medicines Agency (EMA), genomics, hands-on-time (HOT), high-density antibody microarrays, immunohistochemistry, in vitro diagnostic (IVD), limit of detection, limit of quantification, mass spectrometry (MS), medical device, microarray, multiple reaction monitoring (MRM), multiplexing, next-generation sequencing (NGS), premarket approval, profiling, protein, proteomics, reaction monitoring, receiver operating characteristic, regulatory considerations, responsiveness, selected reaction monitoring (SRM), serum, specificity, turnaround time, US Food and Drug Administration (FDA), Medicin och hälsovetenskap, Klinisk medicin, Cancer och onkologi, Medical and Health Sciences, Clinical Medicine, Cancer and Oncology

URL الوصول: https://lup.lub.lu.se/record/26a13906-0f60-4cb3-b691-b0a51bc35b3e
http://dx.doi.org/10.1201/9781003298038-12

المؤلفون: Podemska-Mikluch, Marta

المصدر: Journal of Entrepreneurship and Public Policy, 2019, Vol. 8, Issue 4, pp. 433-441.

URL الوصول: http://www.emeraldinsight.com/doi/10.1108/JEPP-D-18-00059

المؤلفون: Gerald E. Loeb, Frances J. Richmond

المصدر: Frontiers in Robotics and AI, Vol 8 (2021)

مصطلحات موضوعية: regulation, reimbursement, intellectual property, risk management, premarket approval, return on investment, Mechanical engineering and machinery, TJ1-1570, Electronic computers. Computer science, QA75.5-76.95

وصف الملف: electronic resource

Relation: https://www.frontiersin.org/articles/10.3389/frobt.2021.754114/full; https://doaj.org/toc/2296-9144

URL الوصول: https://doaj.org/article/828d8d936c50411d96267714bf158f01

المؤلفون: Paula Pleguezuelos-Beltrán, Patricia Gálvez-Martín, Daniel Nieto-García, Juan Antonio Marchal, Elena López-Ruiz

المصدر: Digibug. Repositorio Institucional de la Universidad de Granada
instname

مصطلحات موضوعية: CEA, cultured epithelial autograft, GELATIN SCAFFOLDS, CAT, Committee for Advances Therapies, PRP, platelet rich plasma, Biomedical Engineering, APPLIED CELL THERAPY, BLA, Biologic License Application, CHMP, Committee for Medicinal Product for Human Use, PHSA, Public Health Service Act, GAGs, glycosaminoglycans, OTAT, Office of Tissues and Advanced Therapies, Biomaterials, Spray, PU, polyurethane, ATMP, advanced therapy medicinal product, DMEM, Dulbecco's Modified Eagle's medium, EU, European Union, NP, Notified body, Tissue engineering, MA, marketing authorization, HA, hyaluronic acid, USA, United States of America, PEG, polyethylene glycol, Skin, Fibrin, PMA, Premarket Approval, FIBRIN SEALANT, FULL-THICKNESS WOUNDS, PRF, platelet rich fibrin, HUMAN ALLOGENEIC FIBROBLASTS, HYALURONIC-ACID, IN-VITRO, GLP, Good Laboratory Practice, HCT/Ps, human cells, tissues, and cellular and tissue-based products, PCL, polycaprolactone, FDA, Food and Drug Administration, QMS, Quality Management System, TE, tissue engineering, ECM, extracellular matrix, EPIDERMAL-CELLS, Hydrogel, GMP, Good Manufacturing Practice, CFR, Code of Federal Regulations, CTD, Common Technical Document, VENOUS LEG ULCERS, EMA, European Medicines Agency, ISO, International Organization for Standardization, Biotechnology, CULTURED EPITHELIAL AUTOGRAFTS

وصف الملف: application/pdf

URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::6a8dfaad3702b342e1ea9b8ae754f1da
https://doi.org/10.1016/j.bioactmat.2022.02.023

المؤلفون: Albert P. Manudhane, Sophie Wang, Harib H. Ezaldein, Jeffrey F. Scott

المصدر: Journal of Dermatological Treatment, Vol 31, Iss 2, Pp 200-203 (2020)

مصطلحات موضوعية: muscle conditioning, muscle toning, pain relief, muscle blood flow, 510(k), maude, premarket approval, abdominal muscles, slendertone, transcutaneous electrical muscle stimulation, Dermatology, RL1-803

Relation: http://dx.doi.org/10.1080/09546634.2019.1587148; https://doaj.org/toc/0954-6634; https://doaj.org/toc/1471-1753; https://doaj.org/article/cf52dc6b0de2437497207ec38d5334f4

الاتاحة: https://doi.org/10.1080/09546634.2019.1587148
https://doaj.org/article/cf52dc6b0de2437497207ec38d5334f4

المؤلفون: Sophie Wang, Albert Manudhane, Harib H. Ezaldein, Jeffrey F. Scott

المصدر: Journal of Dermatological Treatment, Vol 30, Iss 7, Pp 727-729 (2019)

مصطلحات موضوعية: electromagnetic devices, premarket approval, cellulite, rf energy, hair reduction, laser skin resurfacing, acne vulgaris, facial wrinkles, cutaneous lesions, pigmented lesions, vascular lesions, google trends, Dermatology, RL1-803

Relation: http://dx.doi.org/10.1080/09546634.2019.1566589; https://doaj.org/toc/0954-6634; https://doaj.org/toc/1471-1753; https://doaj.org/article/de420c14b17e4486b1729efce1481524

الاتاحة: https://doi.org/10.1080/09546634.2019.1566589
https://doaj.org/article/de420c14b17e4486b1729efce1481524

المؤلفون: Arda, Berna, Ekmekci, Perihan Elif

مصطلحات موضوعية: Equipment and Supplies, Device Approval, Premarket Approval

Relation: Makale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanı; https://hdl.handle.net/20.500.11851/776; 46; 318; 325; WOS:000435148100013

الاتاحة: https://hdl.handle.net/20.500.11851/776
https://doi.org/10.5543/tkda.2018.04706

المؤلفون: Andrew Zhu, Neil P. Sheth, Christian A. Pean, Xiaohan Ying, Michael B. Cross, Ajay Premkumar, Alejandro Gonzalez Della Valle

المصدر: Journal of the American Academy of Orthopaedic Surgeons. 29:e1362-e1369

مصطلحات موضوعية: Medical Device Recalls, medicine.medical_specialty, Medical device, Databases, Factual, Device Approval, Arthroplasty, Replacement, Hip, MEDLINE, 03 medical and health sciences, 0302 clinical medicine, Documentation, Premarket Approval, medicine, Humans, Orthopedics and Sports Medicine, Medical physics, 030222 orthopedics, United States Food and Drug Administration, business.industry, Implant design, 030229 sport sciences, United States, Hip arthroplasty, Surgery, business, Clearance

URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::5e804a6cf27c5938e230b483ebea4329
https://doi.org/10.5435/jaaos-d-21-00138

المؤلفون: Christopher Ty Williams

المصدر: Nursing Clinics of North America. 56:1-21

مصطلحات موضوعية: 030504 nursing, Traditional medicine, business.industry, food and beverages, Herbal drug interactions, complex mixtures, Food and drug administration, 03 medical and health sciences, 0302 clinical medicine, Health care, Premarket Approval, Herbal preparations, Medicine, 030212 general & internal medicine, 0305 other medical science, business, Herbal supplement, health care economics and organizations, General Nursing, Drug approval process

URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_________::a0d09972db1e93ad71dcd8af18f89d4c
https://doi.org/10.1016/j.cnur.2020.10.001

المؤلفون: Esther Abels, Liron Pantanowitz

المصدر: Journal of Pathology Informatics, Vol 8, Iss 1, Pp 23-23 (2017)

مصطلحات موضوعية: De novo, digital, digital pathology, Digital Pathology Association, Food and Drug Administration, premarket approval, regulation, whole slide imaging, Computer applications to medicine. Medical informatics, R858-859.7, Pathology, RB1-214

Relation: http://www.jpathinformatics.org/article.asp?issn=2153-3539;year=2017;volume=8;issue=1;spage=23;epage=23;aulast=Abels; https://doaj.org/toc/2153-3539; https://doaj.org/article/d796e886dc6741228865d67faa858886

الاتاحة: https://doi.org/10.4103/jpi.jpi_11_17
https://doaj.org/article/d796e886dc6741228865d67faa858886

المؤلفون: Kimberly Belsky, Janice Smiell

المصدر: Journal of Burn Care & Research: Official Publication of the American Burn Association

مصطلحات موضوعية: Biomedical Research, AcademicSubjects/MED00910, 02 engineering and technology, Bioinformatics, Food and drug administration, 03 medical and health sciences, PROMOTIONAL MATERIALS, Skin substitutes, Premarket Approval, Humans, Medicine, 030304 developmental biology, Skin, Artificial, Clinical Trials as Topic, 0303 health sciences, Tissue engineered, Tissue Engineering, business.industry, Rehabilitation, Burn treatment, Original Articles, 021001 nanoscience & nanotechnology, United States, Clinical trial, Practice Guidelines as Topic, Government Regulation, Emergency Medicine, Biologics License Application, Surgery, Burns, 0210 nano-technology, business

URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9cb14706853531035402e1f54472aab6
https://doi.org/10.1093/jbcr/iraa210

المؤلفون: Benjamin J. McMichael, Elissa Philip Gentry

المصدر: Journal of Empirical Legal Studies. 17:789-819

مصطلحات موضوعية: Medical device, Actuarial science, business.industry, Legal liability, 05 social sciences, Liability, Immunization (finance), 0506 political science, Education, Supreme court, Tort liability, 0502 economics and business, Health care, Legal Decisions, 050602 political science & public administration, Premarket Approval, Business, 050207 economics, Law

URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1df7c5d85b132ca2171208a1201209cf
https://doi.org/10.1111/jels.12268

المؤلفون: Stan Benjamens, Bertalan Meskó, Pranavsingh Dhunnoo

المصدر: npj Digital Medicine, Vol 3, Iss 1, Pp 1-8 (2020)
Npj digital medicine, 3(1):118. Nature Publishing Group
NPJ Digital Medicine

مصطلحات موضوعية: Medical device, Computer applications to medicine. Medical informatics, MEDLINE, R858-859.7, Medicine (miscellaneous), Health Informatics, lcsh:Computer applications to medicine. Medical informatics, Article, 03 medical and health sciences, Health services, 0302 clinical medicine, Health Information Management, Premarket Approval, Medicine, 030212 general & internal medicine, business.industry, Online database, Computer Science Applications, Clinical Practice, Outcomes research, General practice, lcsh:R858-859.7, Artificial intelligence, business, Algorithm, 030217 neurology & neurosurgery

وصف الملف: application/pdf

URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::7b02674c20b3181f152c0bb38faa0ad4
https://doaj.org/article/57ebc19d581944ad8bbd6b42f5de1019

المؤلفون: Jon G. Dishler, Stephen Slade, Stefanie Seifert, Steven C. Schallhorn

المصدر: Ophthalmology. 127:1020-1034

مصطلحات موضوعية: 0303 health sciences, medicine.medical_specialty, Visual acuity, genetic structures, business.industry, Emmetropia, Astigmatism, medicine.disease, eye diseases, Food and drug administration, Clinical trial, 03 medical and health sciences, Ophthalmology, 0302 clinical medicine, 030221 ophthalmology & optometry, medicine, Premarket Approval, Small incision lenticule extraction, medicine.symptom, business, Dioptre, 030304 developmental biology

URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_________::5f4f9cd733ba0411282b67a0c293a00b
https://doi.org/10.1016/j.ophtha.2020.01.010

المؤلفون: Amanda Suggs, Jeffrey F. Scott, Miesha Merati, Sheena T. Hill, Barbara Reichert, Harib H. Ezaldein

المصدر: Lasers in Surgery and Medicine. 52:837-841

مصطلحات موضوعية: Retrospective review, medicine.medical_specialty, business.industry, Dermatology, 01 natural sciences, 010309 optics, Food and drug administration, 030207 dermatology & venereal diseases, 03 medical and health sciences, 0302 clinical medicine, 0103 physical sciences, Premarket Approval, Medicine, Surgery, business, Clearance

URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_________::d97bd0f478e91041ee6e6734e05164f1
https://doi.org/10.1002/lsm.23236

المؤلفون: Fekete, Stephanie P.

المصدر: Catholic University Law Review

مصطلحات موضوعية: medical device, small business, Food and Drug Administration, FDA, premarket, postmarket, premarket classification, safety and efficacy, 510(k), premarket approval, PMA, Federal Food, Drug, and Cosmetic Act, Medical Device Amendments of 1976, Safe Medical Device Act of 1990, Food and Drug Administration Modernization Act of 1997, Medical Device User Fee and Modernization Act of 2002, safety and performance, Contact Lens, Consumer Protection Law, Food and Drug Law, Health Law and Policy, Law, Other Law

وصف الملف: application/pdf

Relation: https://scholarship.law.edu/lawreview/vol65/iss3/9; https://scholarship.law.edu/context/lawreview/article/3375/viewcontent/Fekete_605_634.pdf

الاتاحة: https://scholarship.law.edu/lawreview/vol65/iss3/9
https://scholarship.law.edu/context/lawreview/article/3375/viewcontent/Fekete_605_634.pdf