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For acceptance, the tested specimen shall be bent through 180° over a diameter equal to twice the thick- ness of the specimen. Bending axis shall be perpendicular to the direction of the test specimen. Unless otherwise specified, the bend test system shall be a root bend; i.e., the ...
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even when combined with the EC proposal to reduce the EMAs maximum assessment time from 210 to 180 active review days,this amounts to a theoretical net reduction in time to approve a new medicine of only 51 days.Given that the above studies point towards a 100-to-250-day gap between the...
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