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Fluconazole (Diflucan) Package Insert

DIFLUCAN (fluconazole), the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration, as a powder for oral suspension.

GEO-D02 and MVA-HIV62B Vaccine

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GEO-D03 and MVA-HIV62B Vaccines (Preventative)

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GLA-SE

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Glecaprevir and Pibrentasvir

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GSK1265744 (Cabotegravir)

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Guidelines for Electronic Submissions Via Email-EPR Guidelines

Guidelines for Electronic Submissions Via Email-EPR Guidelines

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HEC Placebo Gel

Hepatitis B Vaccine Recombinant (Engerix-B)

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Hepatitis B Vaccine Recombinant, Adjuvanted (Heplisav-B)

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Hepatitis B Vaccine Recombinant, Adjuvanted (Heplisav-B) Investigator's Brochure

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High Level Summary of Changes for the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 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 changes detailed below when compared with the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0 – December 2004 (…

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HIV-1 Multiantigen pDNA Vaccine and Human IL-12 pDNA

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HPTN - Expedited Reporting to DAIDS and DAERS Refresher

.zip files contains Presentation to HPTN/IMPAACT Annual Meeting on Expedited Reporting to DAIDS and DAERS refresher course Expedited reporting via DAERS - Case Study

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HVTN - Expedited Reporting to DAIDS and DAERS Refresher

.zip file contains: Presentation to HVTN Annual Meeting on Expedited Reporting to DAIDS and DAERS refresher course; Expedited reporting via DAERS - Case Study

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Hydroxychloroquine Sulfate Package Insert

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IBC RAC Guidance

Guidance and requirements for daids-supported research involving recombinant DNA.

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IHV01

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Imatinib Mesylate Package Insert

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IMPAACT - Expedited Reporting to DAIDS and DAERS Refresher

.zip files contains: Safety training presentation on expedited reporting to DAIDS and a refresher on DAERS Case study handout Meeting for HPTN and IMPAACT networks was held June 2016.

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IND Protocol Lists

List of IND protocols having CRF/Pharmacy records that will not be stored by DAIDS.

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Instructions for Authorization and Transfer of CRFs and Pharmacy Records to the DAIDS RSC

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Instructions for Authorization and Transfer of CRFs and Pharmacy Records to the DAIDS RSC

Instructions for the transfer of case report forms, (CRF) and pharmacy records to the DAIDS regulatory support center, (DAIDS RSC).

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Instructions Page for the DAIDS Protocol Specific Informed Consent Template 2/23/2016

Informed Consent documents are in the process of being updated to be compliant with the revised Common Rule.

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Instructions Page for the DAIDS Protocol Specific Informed Consent Template 7/24/2013

DAIDS protocol specific informed consent template—general use.

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