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Devices in the high-risk category must meet requirements for approval before they can be sold, and may require more study, reporting or other controls to assure safety and effectiveness.
That is enough to satisfy the F.D.A. requirements for approval.
Empirically, the data generated from the chosen CROs should meet the regulatory requirements for approval.
A spokeswoman for BP said although the decision meant BP's application didn't meet Nopsema's regulatory requirements for approval, it wasn't a rejection.
The Agriculture Department said the corn met the statutory requirements for approval, in that it was not a pest that would harm plants.
More than 500 additional applications were completed but withdrawn, in many cases after the applicants were advised that they did not meet some of the basic requirements for approval.
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Prior informed consent to join the evaluation was obtained from participating NHS trusts, and researchers complied with local requirements for approvals on a case by case basis.
The research foundation could then choose which organizations received grants for the work, without a requirement for approval by government agencies.
As part of the deal, Dow agreed to sell a 50percentt stake in Polimeri Europa, which belongs to Union Carbide, to Enichem to comply with a European Union antitrust requirement for approval of Dow's acquisition of Union Carbide.
It also took about a year to find a formulation that would produce the same level of the three drugs in a patient's blood as the three drugs taken separately, which is the main requirement for approval of a combination drug.
There are also some types of loans that do not examine your credit as a requirement for approval; those with poor credit should inquire as to which types of loans fall into this category.
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requirements for rehabilitation
requirements for consensus
apply for approval
requirements for backing
measures for approval
rationale for approval
requirements for admission
stipulated for approval
requirements for licensure
requirements for recognition
requirements for application
requirements for accreditation
needs for approval
request for approval
qualifications for approval
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com