FDA Package definition

FDA Package means the FDA and state regulatory filings, approvals, correspondence and audit reports provided by the Company to the Parent and its counsel.

FDA Package means the FDA and state regulatory filings, approvals, correspondence and audit reports previously sent by PCT to Parent and its counsel.

FDA Package means the FDA and state regulatory filings, approvals, correspondence and audit reports provided by Amorcyte to Parent and its counsel.

Examples of FDA Package in a sentence

• FDA Package Insert for BioPort Corp., Anthrax Vaccine Adsorbed, BioThrax, (January 31, 2002), 6, http://www.fda.gov/Cber/label/biopava0131022lb.pdf.

• AHA (2019), guidelines do not support chemical thrombolysis if the patient has had an ischemic stroke within the past 3 months; but this has been excluded in the FDA Package Inert (2015) guidelines as a contraindication to thrombolytic therapy [15].

• FDA Package Insert for Magnesium Sulfate: This document and any subsequent revisions will be filed in this section.

• Allergic_Reaction-Anaphylaxis_Oct_14.Docx 5/4/2015 Diphenhydramine Hydrochloride (Hospira, Inc.): FDA Package Insert Med Library.org Prescription Medications Diphenhydramine Hydrochloride By Hospira, Inc.

• According to the AHA (2019) guidelines, chemical thrombolysis is indicated within 4.5 hours of the onset of symptoms, the US FDA Package Insert (2015) allows a tight window of within 3 hours from the onset of symptoms, a criteria our patient wouldn't have met [3].

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More Definitions of FDA Package

FDA Package means the FDA and state regulatory filings, approvals, correspondence and audit reports previously sent by PCT to Parent and its