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Entities that are not duty holders in law have no enforceable responsibilities and, accordingly, are not exposed.2 Adopting the same systematic approach to both societal and managerial risks, as all duty holders in law are exposed per se, the next step is to assess their vulnerabilities.
FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities.
FDA guidances generally do not establish legally enforceable responsibilities for industry, unless specific regulatory or statutory requirements are present.
While the FDA's guidance documents do not establish legally enforceable responsibilities, the recommendations provided are typically considered to be the best 'road map' for gaining approval for clinical use of a given technology.
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It can thus be seen that philanthropic responsibility is actually not an enforceable responsibility at all, but rather one that involves purely discretionary activities.
Many companies manage our data; most of them have no enforceable legal responsibility to us.
Both parties have acknowledged that in practice they are unlikely to go beyond the symbolic and use the vehicle of a bill of rights to introduce a legally enforceable catalogue of responsibilities or duties that would impact on us all.
Although the US FDA has released two guidance documents on the use of social media platforms for presenting benefit/risk information on prescription drugs and medical devices [ 9], these documents are more concerned with product promotion than surveillance and "do not establish legally enforceable rights or responsibilities" [ 10].
The tribes invoked the federal Indian trust responsibility, which, as the Bureau of Indian Affairs explains it, is "a legally enforceable fiduciary obligation on the part of the United States to protect tribal treaty rights, lands, assets, and resources, as well as a duty to carry out the mandates of federal law".
Thus despite the resources and time that negotiating such a framework convention will require, establishing a set of enforceable and justiciable international responsibilities for states that would ensure a human rights-based approach to TB prevention, care and management, would be well worth the resources expended.
This is a positive step, but it does not relieve Albany of the responsibility to establish uniform and enforceable statewide standards.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com