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FDA guidance - General, Drug and Biologicals, Medical Devices, and FDA operations

The term “ test article ” is found in the FDA regulations on Protection of Human Subjects ( 21 CFR 50.3, Definitions (j)). The term includes drugs (including botanicals, biologicals , and gene therapy, and genetically derived products that meet the...

Guidance

Oct 21, 2020

Prisoners in Research

Convened Board review and approval of research designed to study incarcerated persons, or persons likely to become incarcerated , is a multistep process and must be conducted in accordance with the requirements in 45 CFR 46 Subparts A (Common Rule)...

Guidance

Sep 21, 2020

Waiver or Alteration of HIPAA Authorization

To use and/or disclose Protected Health Information (PHI) for research purposes , the HIPAA Privacy Rule in general requires that researchers obtain signed authorization from the individual. An IRB can grant a Waiver of HIPAA Authorization to permit...

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Policies

Jan 20, 2020

Policy on the Use of Expired Drugs and Medical Materials

This policy defines the expectations for the appropriate use and storage of expired drugs and medical materials.

SOPs

Dec 14, 2018

Procedures to Reduce Human Exposure to Orf and Q Fever

To clarify procedures necessary to safely handle sheep to decrease the risk of human exposure to contagious ecthyma (the causative agent of orf ) and Coxiella burnetii (the causative agent of Q fever ).

Forms

Aug 5, 2020

Technical Services Request Form

The In-Vivo Animal Core (IVAC) can perform a variety of technical services, including animal randomization, drug preparation, dosing and blood collection, and all clinical observations. Services are offered on a fee-for-service basis. Requests...

Tags: IVAC