Drugs

Drugs

Terms in relation to substances, other than food, that have medicinal, intoxicating, performance enhancing, or other effects when put into the body of a human or animal.

Industry: Pharmaceutical

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Drugs

Review

Pharmaceutical; Drugs

A review is the basis of FDA's decision to approve an application. It is a comprehensive analysis of clinical trial data and other information prepared by FDA drug application reviewers. A review ...

Review classification

Pharmaceutical; Drugs

The NDA and BLA classification system provides a way of describing drug applications upon initial receipt and throughout the review process and prioritising their review.

Patient package insert (PPI)

Pharmaceutical; Drugs

A patient package insert contains information for patients' understanding of how to safely use a drug product.

Over-the-counter drugs (OTC)

Pharmaceutical; Drugs

FDA defines OTC drugs as safe and effective for use by the general public without a doctor's prescription.

Product number

Pharmaceutical; Drugs

A product number is assigned to each drug product associated with an NDA (New Drug Application). If a drug product is available in multiple strengths, there are multiple product numbers.

Route

Pharmaceutical; Drugs

A route of administration is a way of administering a drug to a site in a patient. A comprehensive list of specific routes of administration appears in the CDER Data Standards Manual.