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That brief description barely scratches the complexity of the rule, which when it was proposed in 2015 took up 262 pages in the Federal Register, consisting of 150 pages of explanatory preamble and 112 pages of regulatory text.
This catchall phrase could reasonably be construed to encompass a nonbinding commitment from a physician to prescribe a particular drug, and nothing in the statutory or regulatory text or the DOL's prior guidance plainly requires a contrary reading.
Right now, divisions of statutory and regulatory text below the section level ("subsection containers") are among the most prominent examples of "missing markup"; they are provided for in the legislative XML DTDs at (eg). xml.house.gov, but do not survive into the FD/SYS versions from GPO.
Or that the ugly regulatory text was obscured.
Each Advisor includes links to more detailed information that may be useful to the user, such as links to regulatory text, publications and organizations.
The risk cycle issue should be explicitly noted in the regulatory text to raise awareness among the registrants of this topic.
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In particular, we discuss how one can form architectural requirements which are linked to regulatory texts.
Since the changes to official regulatory texts generally occur at a slower pace than the scientific state-of-the-art, and because of the lack of a harmonized approach, both scientific and regulatory guidance documents are necessary.
These expert recommendations reflect the current position of the scientific community and potentially address aspects not covered satisfactorily by regulatory texts while taking into account the latest advancements in experimental methodologies.
Nevertheless, even with the more recent recourse to subject-specific regulatory texts with relatively strong binding potency, such as the European Directive 98/44/EC on the legal protection of biotechnological inventions, defining the exact contours of patentability exclusions with regards to biological material has become an increasingly complex task.
In 2008, this committee proposed a national policy for the development of palliative care, accompany the implementation and deployment of this policy, and evaluate application of legislative and regulatory texts concerning palliative care and end of life supportive care.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com