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

patient package insert (PPI)

Pharmaceutical; Drugs

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

pharmaceutical equivalents

Pharmaceutical; Drugs

FDA considers drug products to be pharmaceutical equivalents if they meet these three criteria: * they contain the same active ingredient(s) * they are of the same dosage form and route of ...

prescription drug product

Pharmaceutical; Drugs

A prescription drug product requires a doctor's authorization to purchase.

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.

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 prioritizing their review.

reference listed drug (RLD)

Pharmaceutical; Drugs

A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic ...