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Because biologics are more complex than small-molecule drugs and because biosimilars are similar but not identical to their reference products, regulatory authorities around the world have recognized the need for a unique approval pathway for biosimilars that is distinct from the approval pathway for generics and that addresses these differences 8– 10.
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Oregon's hospitals come in all shapes and sizes, each with unique approval processes for engaging in data sharing, prioritization of voluntary public health projects, coordination of Meaningful Use efforts and IT support.
The Conan Doyle Estate describes itself as the "only company associated with the family" and offers "a unique seal of approval" bearing the profiles of Holmes and Watson.
"The Arctic is a unique treasure," she tweeted in response to news of the approval being given.
That would be an especially untimely development, given that in Washington, the Securities and Exchange Commission is reviewing the status of a unique, nine-year-old arrangement that gives virtually automatic S.E.C. approval to securities documents prepared in Canada according to American guidelines.
The regulatory approval of the first rotavirus vaccine was a unique case.
Special agents were used, such as carbapenem, which require a unique, restrictive, computerized prescription system that can only be accessed with approval of an infectious disease specialist.
In a tweet last August, a day after Obama gave final approval to Shell drilling in the Chukchi sea, Clinton said: "The Arctic is a unique treasure.
Under MD Anderson Cancer Center Orlando Institutional Review Board approval and informed consent, prospectively collected voided urine samples (50 mL) were assigned a unique identifying number before immediate laboratory processing.
Ethics approval was received from the local ethics committee (H-C-2007-0033) and the RCT was registered with a unique trial registration number (ISRCTN96241850).
Ethics approval was received from the local ethics committee (H-C-2007-0033) and the clinical trial was registered with a unique trial registration number (ISRCTN96241850).
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