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5 Though an orphan drug designation does not formally change the statutory approval standard, studies show that orphan drugs are often approved on the basis of clinical trials that would be insufficient for traditional non-orphan products, such as small, non-randomized, unblinded, single arm trials.
Impact assessments (IA) are then carried out to justify the selection and subsequent statutory approval.
The production and statutory approval of the towns' plans and schemes advanced in concert with their actual settlement.
Indeed, as Table 1 suggests, Bedouin resettlement to Tel Sheva, Rahat, Segev Shalom, Arara and Hura commenced a decade or more prior to their actual final statutory approval, only further complicating the process of family relocation.
Table 1 Dates of Bedouin towns initial settlement and approval of comprehensive local outline schemes Town Initial housing lots allocation and settlement Statutory approval of comprehensive local outline schemes Tel Sheva 1967 1986 Rahat 1971 1989 Segev Shalom 1979 1991 Kseifa 1982 1991 Arara 1982 1993 Laqiya 1985 1988 Hura 1989 1999.
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The transaction is subject to the vote of Ranbaxy shareholders, as well as customary regulatory and statutory approvals.
The terms of the acquisition, which is expected to close later this year following statutory approvals, regulatory reviews and customary closing conditions, were not disclosed.
Therefore, we applied the validated SANGRA (South Asian Names and Group Recognition Algorithm) algorithm (Maringe et al, 2013), after ethical and statutory approvals, to flag all South Asian patients in the national cancer registry, making use of their distinctive names.
The Agriculture Department said the corn met the statutory requirements for approval, in that it was not a pest that would harm plants.
The merger is subject to statutory and regulatory approvals and will take some four months to go through.
We hold statutory and ethical approvals to analyse the data from West Midlands Cancer Intelligence Unit and Comprehensive Cancer Centre The Netherlands registry data.
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