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If reactions first appeared or significantly worsened at a specific dose level, discuss the following options with your healthcare provider: extended time at the current dose before escalating further, smaller escalation increments , pre-injection antihistamine protocol, or exploring whether the therapeutic goals can be achieved at a lower dose

doi: 10.11648/j.avs.20150304.13 114 KhanW

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We propose that, for the purposes of this policy, submission of a request for marketing authorization by the FDA would mean that the applicant has submitted a complete application to FDA, and that the application has an active status with FDA (such as not in a Hold status or having received a Complete Response Letter)