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Paclitaxel 6 mg/ml Concentrate for Solution for Infusion, Package Insert

Therapeutic Indications: Ovarian carcinoma: in the first-line chemotherapy of ovarian cancer, paclitaxel is indicated for the treatment of patients with advanced carcinoma of the ovary or with residual disease (> 1 cm) after initial laparotomy, in combination with (cisplatin or carboplatin)In…

Parameter Level Summary of Changes for the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017

This DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected version 2.1, July 2017 supersedes version 2.1 of the table dated March 2017. Changes to note in this corrected version 2.1 of the Severity Grading Table are parameter specific and are highlighted below in…

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Parameter Level Summary of Changes for the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, v. 2.0

The Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0 contains a number of parameter level (i.e., adverse event) severity grading criteria changes detailed below when compared with the Division of AIDS Table for Grading the S everity of Adult…

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Parameter Level Summary of Changes for the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Event

The Division of AIDS Table for grading the severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table) is a collection of commonly encountered adverse events and their descriptive terminology utilized for severity grading. As part of its standard review processes, DAIDS reassessed the “…

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PGDM1400

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PGDM1400LS (VRC-HIVMAB0112-00-AB)

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PGT121

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PGT121.414.LS (VRC-HIVMAB0107-00-AB)

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Poly-ICLC (Hiltonol)

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Pramipexole Dihydrochloride

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Pretomanid (PA-824)

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Priftin (rifapentine) Tablets, Package Insert

PRIFTIN is a rifamycin antimycobacterial drug indicated in patients 12 years of age and older for the treatment of active pulmonary tuberculosis (TB) caused by Mycobacterium tuberculosis in combination with one or more anti-tuberculosis (anti-TB) drugs to which the isolate is susceptible. (1.1) *…

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Progesterone

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Protocol Development Lifecycle Resource

Protocol Development Lifecycle flowchart

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Protocol Registration at a Glance Quick Reference Card

Quick reference card for protocol registration at a glance.

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Protocol Registration Checklist

Division of AIDS (DAIDS) protocol registration checklist. NOTE: This form is not required if submitting materials through the DAIDS Protocol Registration System (DPRS).

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Protocol Registration Checklist (Alternate Format)

Division of AIDS (DAIDS) protocol registration checklist. NOTE: This form is not required if submitting materials through the DAIDS Protocol Registration System (DPRS).

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Pyrazinamide Package Insert

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Quercefit (Quercetin Phospholipid)

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Quick Reference Card - Adverse Event Checklist

Use this to make sure you don't miss any required pieces of information when recording and reporting an adverse event.

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Quick Reference Card - Narrative Case Summary and AE/SAE/EAE Essentials

One-sheet references for writing a narrative case summary of an adverse event and for evaluation and follow-up.

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Raltegravir (Isentress)

The following side effects have been associated with the use of raltegravir:

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Relevant Communications and Vendor Oversight Communication

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Remdesivir (Veklury)

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Required Documentation Based on 45 CFR 46

Required documentation of risk/benefit category and approval of clinical studies for inclusion of children by institutional review boards/ethics committees based on 45 CFR 46, Subpart D.

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