Glossary

Investigational New Drug

A document filed with the FDA prior to clinical trial of a new drug. It gives a full description of the new drug, where and how is manufactured, all QC information, etc. The IND is followed by NDA (New Drug Application).

An investigational new drug safety report is generated by a sponsor in response to serious and unexpected adverse events occurring in a research study at any participating site. The IND Safety Report is submitted to the FDA and distributed to all participating research sites. It is possible that an IND safety report could be “expected” and/or “not related” and therefore not reportable to the Committee as a Serious Adverse Event.

This index features an alphabetical listing of drugs that have been the subject of a Public Health Advisory, a Healthcare Professional Information sheet, an Early Communication About an Ongoing Safety Review, or other important information.

An indication is a specific medical condition being addressed by the investigational drug.

A condition or an anomaly of a localized area that has not been classified as being accepted or rejected.

A system that is not expected to have a direct impact on product quality, but typically will support a Direct Impact System. These systems are designed and commissioned following Good Engineering Practice only.

System that is not expected to have a direct impact on product quality, but typically will support a Direct Impact System. These systems are designed and commissioned following Good Engineering Practice only.

An engineering system considered not to have a direct impact on product quality.

A system or facility that is not expected to have a direct impact on product quality but that supports or links to one that does.

Data that do not include personal identifiers, but link the identifying information to the data through use of a code. These data are still considered identifiable by the Common Rule. To determine what data may be considered identifiable, please see deidentified.

A subset of health information that identifies the individual or can reasonably be used to identify the individual.

A low-molecular-weight compound or a physical agent that is bound by a repressor so as to produce a complex that can no longer bind to the operator; thus, the presence of the inducer turns on the expression of the gene(s) controlled by the operator.

(QA) Procedures and criteria recognized as acceptable practices by peer professional, credentialing, or accrediting organizations.

A support structure that makes no chemical contribution, and whose only function is support. Physiologically it is a neutral or immobile unit.

A necrotic area of tissue resulting from failure of local blood supply.

(NBS) A sequence of program statements that can never be executed. Synonymous: Dead Code.

For a microorganism to enter, invade, or inhabit another organism, causing infection or contamination.

Contaminated with extraneous biological agents and therefore capable of spreading infection.

The invasion of any living organisms by disease-causing micro-organisms, which proceed to establish themselves, multiply, and produce various clinical signs in their host.

Able to cause disease in a susceptible host.

Typically, a proliferating virus, bacterium or parasite that causes a disease in plants or animals.

The characteristic of a disease agent that embodies capability of entering, surviving in, and multiplying and causing disease in a susceptible host.

Capable of producing infection.

The entry of air from an adjoining room or from outdoors through wall and ceiling openings due to a difference in air pressure between the two areas.