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Those projects, however, rely on a long process that requires Congressional approval, studies by the Army Corps of Engineers and, finally, a lot of federal money that usually comes as budget add-ons, or earmarks.
The agency is requiring the companies that produce the implants to oversee big post-market approval studies and monitor women who get the implants.
Throughout most direct antiviral agent (DAA) approval studies, HCV RNA cutoffs and endpoints were established with the COBAS TaqMan assay for use with the High Pure System (HPS/CTM).
One of the benefits of such a system is that researchers can more readily target drug approval studies to predicted high-response populations, and cut years from the drug research process.
Because of its recent approval, studies evaluating the cost-effectiveness of liraglutide are scarce.
These examples also included approval studies of atypical antipsychotics, where a correct calculation would seem to be particularly important [ 6].
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Recently a multi-center, post-market approval study similarly demonstrated a comparable BTT rate.
KP assisted with ethics approval, study design and implementation for Phase II.
The same processes for ethics approval, study information and data collection outlined above will be applied to the interview data.
For one approval study [ 6] an erroneous calculation of the PANSS PC has already been shown [ 2].
As the developer of a therapeutic, Genentech had no choice but to conduct premarket-approval studies under strict FDA-approved protocols.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com