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10-1074

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16055 NFL Delta Gly4 Env Protein Trimer, Adjuvanted with 3M-052 AF + Alum

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2020 IND Lists of Studies having CRF/Pharmacy Records That Will Not be Stored by DAIDS

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2020 non-IND Lists of Studies having CRF/Pharmacy Records That Will Not be Stored by DAIDS

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426c.Mod.Core-C4b, Adjuvanted

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Abacavir Sulfate (Ziagen) Risk List

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

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Abacavir Sulfate/Dolutegravir/Lamivudine (Triumeq) Package Insert

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Abacavir/Lamivudine (Epzicom) Package Insert

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ABT-267, ABT 333, ABT-450 and Ritonavir

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Accessing and Maintaining Site Personnel Information in the DAIDS-ES

Tutorial guide, with screenshots, for the DAIDS-ES system.

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ACTG - Expedited Reporting to DAIDS and DAERS Refresher

Presentation on expedited reporting to DAIDS plus a case study on expedited reporting via DAERS.

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ACTG IND Study Financial Disclosure Form Template

ACTG IND study financial disclosure form template.

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Addendum 1, Female Genital Grading Table for Use in Microbicide Studies

Guidance table for grading the severity of adult and pediatric adverse events with female genital involvement during microbicide studies.

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Addendum 2 Male Genital Grading Table for Use in Microbicide Studies

Guidance table for grading the severity of adult and pediatric adverse events with male genital involvement during microbicide studies.

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Addendum 3 Rectal Grading Table for Use in Microbicide Studies (Clarification dated May 2012)

Guidance table for grading the severity of adult and pediatric adverse events with rectal involvement during microbicide studies.

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Algorithm for Determining Whether Site Specific Informed Consent Forms will be Reviewed at the Time of Initial Protocol Registration

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Azithromycin Package Insert

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B63521^11 gp120

BCG Vaccine

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Bedaquiline (Sirturo) Package Insert

SIRTURO is a diarylquinoline antimycobacterial drug indicated as part of combination therapy in adults (18 years and older) with pulmonary multi-drug resistant tuberculosis (MDR-TB). Reserve SIRTURO for use when an effective treatment regimen cannot otherwise be provided. Administer SIRTURO by…

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BG505 SOSIP.664 gp140, Adjuvanted with 3M-052-AF + Alum, or CpG 1018 + Alum, or GLA-LSQ, or Alum

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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

Cemiplimab (REGN2810)

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