Medical devices

Medical devices

Any instrument, appliance or machine that facilitates the prevention,diagnosis and treatment of illness, physical or mental injury, by a medical professional.

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Medical devices > Clinical trials

natural history study

Pharmaceutical; Clinical trials

Study of the natural development of something (such as an organism or a disease) over a period of time.

new drug application (nda)

Pharmaceutical; Clinical trials

An application submitted by the manufacturer of a drug to the FDA - after clinical trials have been completed - for a license to market the drug for a specified indication.

off-label use

Pharmaceutical; Clinical trials

A drug prescribed for conditions other than those approved by the FDA.

open-label trial

Pharmaceutical; Clinical trials

A clinical trial in which doctors and participants know which drug or vaccine is being administered.

orphan drugs

Pharmaceutical; Clinical trials

An FDA category that refers to medications used to treat diseases and conditions that occur rarely. There is little financial incentive for the pharmaceutical industry to develop ...

peer review

Pharmaceutical; Clinical trials

Review of a clinical trial by experts chosen by the study sponsor. These experts review the trials for scientific merit, participant safety, and ethical considerations.

phase i trials

Pharmaceutical; Clinical trials

Initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of ...