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

New molecular entity (NME)

Pharmaceutical; Drugs

A New Molecular Entity is an active ingredient that has never before been marketed in the United States in any form.

Medication guide

Pharmaceutical; Drugs

A medication guide contains information for patients on how to safely use a drug product.

Biological products include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. Biologics ...

Abbreviated new drug application (ANDA)

Pharmaceutical; Drugs

An abbreviated new drug application (ANDA) contains data that, when submitted to FDA's centre for Drug Evaluation and Research, Office of Generic Drugs, provides for the review and ultimate approval ...

Biologic licence application (BLA)

Pharmaceutical; Drugs

Biological products are approved for marketing under the provisions of the Public Health Service (PHS) Act. The Act requires a firm who manufactures a biologic for sale in interstate commerce to hold ...

Approval history

Pharmaceutical; Drugs

The approval history is a chronological list of all FDA actions involving one drug product having a particular FDA Application number (NDA). There are over 50 kinds of approval actions including ...

Active ingredient

Pharmaceutical; Drugs

An active ingredient is any component that provides pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure ...