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In essence, these companies misjudged the difficulties of mastering the testing and approval process.
eTHX certification is pending final testing and approval by THX Ltd.
And even after a lengthy testing and approval process, drugs may have unintended consequences.
The description of the potential side effects is, therefore, an important element of the testing and approval procedure for PPPs.
--Eliminate handrdous pestimproveand impesticideticide monitoring, testing and approval.
This required passing stringent tests and approval by the IRS to obtain conversion.
Furthermore, increasing scrutiny and accelerated approval pathways provide a driving force to be even more efficient with limited regulatory resources.
The Biologics Price Competition and Innovation Act created an abridged approval pathway for biosimilars.
And after over five years of delay, the approval pathway is finally in place leading to new, competitively priced treatments like Zarxio.
Compared with small-molecule generics and new biologic agents, biosimilars are evaluated via an abbreviated approval pathway (Table 1) [ 2].
The shorter approval pathway requires companies to show a product is "substantially equivalent" to one already on the market and typically does not require human testing.
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CEO of Professional Science Editing for Scientists @ prosciediting.com