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Bictegravir/Emtricitabine/Tenofovir Alafenamide (Biktarvy) Package Insert

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Bleomycin for Injection, Package Insert

Bleomycin for Injection should be considered a palliative treatment. It has been shown to be useful in the management of the following neoplasms either as a single agent or in proven combinations with other approved chemotherapeutic agents.

Bleomycin Sulfate Package Insert

Temporary importation of Bleomycin Sulfate Powder for Injection, 15,000 International Units (IU) to address drug shortage issue

Cabotegravir (Vocabria)

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Cabotegravir and Rilpivirine (Cabenuva)

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CD4BS CH505M5 Pr-NP1, Adjuvanted

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CH505 M5 gp120

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CH505 TF chTrimer

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CH505M5 N197D mRNA-gp160 and CH505 TF mRNA-gp160

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ChAdOx1.HIVconsv62

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ChAdOx1.tHIVconsv1

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Clinical Trial Application Submission Guidance

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ClinicalTrials.gov Flowcharts

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Clofazimine (Lamprene) Package Insert

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CMV-MVA Triplex

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Combivir (lamivudine and zidovudine) Tablets, Package Insert

COMBIVIR, a combination of 2 nucleoside analogue reverse transcriptase inhibitors, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. 

Completion Instructions for the DAIDS EAE Form

Line by line instructions for how to complete the Expedited Adverse Events reporting form.

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Cover Memo, January 18, 2017, RE: Lists of IND and non-IND protocols having Case Report Forms (CRFs) and Pharmacy Records that will not be stored by DAIDS

Lists of IND and non-IND protocols having case report forms (CRFs) and pharmacy records that will not be stored by DAIDS .

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Creating a New Submission in the DPRS Quick Reference Card

Quick reference card for creating a new submission in the DPRS.

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CRF Master Inventory List Template

CRF master inventory list template.

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CRS Leader and CRS Coordinator User Guides

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DAERS Access User Guide for EAE Reporter and Submitter Rights

Term definitions and access rights for Reporters and Submitters using DAERS.

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DAERS Access User Guide for EAE Reporter and Submitter Rights

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DAERS Reference Guide for Site Enrollment Users

Technical guide to the DAERS system for Site Enrollment users.

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DAERS Reference Guide for Site Reporters and Study Physicians

Detailed manual on the DAERS system for Site Reporters and Study Physicians.

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