Clinical investigators or study sponsors often face challenges when designing clinical trials on human cells and tissue products with the goal of obtaining premarket approval owing to the unique characteristics of products in this category.
The study design and its procedures have been presented to the local ethics committee who, according to the Danish law, did not consider the study for ethical approval, owing to the observational nature of the study.
The study design and its procedures have been presented to the local ethics committee (record number "request 187/2015") who, according to the Danish law, did not consider the study for ethical approval, owing to the observational nature of the study.
41 The Regional Ethical Committee of Southeastern Norway, REK South East granted this project an exemption from formal approval owing to the lack of patient data (Ref: 2014/197/REK South East).
The carious teeth were extracted owing to clinical indication, with the approval of the Institutional Review Board IRBB).
However, owing to the descriptive and non-interventional design of this survey, approval by an ethics committee was not required, and the study was not submitted to registration.
Ethical approvals were obtained from the Zayed University and the University of Liverpool, owing to the respective affiliation of the researchers to these institutions.
Institutional review board approval was obtained for this study, and informed patient consent was waived owing to the retrospective nature of the study.
While antibodies are very efficient, their cost-effectiveness has always been discussed owing to their high costs, accumulating to more than one billion dollars from preclinical development through to market approval.
Venezuela and Nigeria are unreliable, owing to civil strife.
