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Abatement

A diminution, decrease or easing of pain or other symptoms, as when after a drug or other treatment/product has been started, stopped, or the dosage changed.

Account

Being recognized by the Portal system as entitled to perform certain functions within the application—and requiring a username and password.

Active (Status)

Identifies a record (such as a user-account record) that is currently valid and active.

Additional Information

Information requested or received following the receipt of the initial report. This information is \"supplemental\" to initial submission.  (See \"Follow-up Report\")

Administrator user

A Portal user that is responsible for managing the Safety Reporting application--typically responsible for installing and configuring the application’s software, establishing and managing user accounts, applying any software upgrades, and backup/recovery tasks.

Adulteration

A violation of the Federal Food, Drug, and Cosmetic Act which includes products that are defective, unsafe, not shown to be safe, filthy, or produced under insanitary conditions. The term also includes products which are manufactured under procedures and controls which do not comply with Current Good Manufacturing Practice regulations, as well as new animal drug products which are not the subject of approval. (Detailed definitions of adulteration are in the Act itself, and have been developed in regulations and by the courts.)

Adulteration Origination Site

The source of the impurity (e.g., added extraneous, improper, or inferior ingredients); the site at which the adulteration originated and the first link in the distribution chain.

Adverse Event Report

Direct communication from an identifiable first-hand reporter that includes at least the following information: (1) an identifiable reporter, (2) an identifiable animal(s) or human(s), (3) an identifiable product or procedure, (4) one or more adverse events.  (One animal or one human being, or a medically appropriate group exhibiting similar clinical signs should be included in a single report.  See also \"Safety Report.\")

AE

Adverse Event

AER

See \"Adverse Event Report.\"

Alert

An onscreen notification to the user from the Safety Reporting Portal system

Allergenic Products

Biologicals intended to provoke an immunologic response, usually employed in progressive doses to desensitize a patient to a particular allergen.

Alpha-letter character

One of the 26 letters of the English-language alphabet. (Compare to \"Alphnumeric.\")

Alphanumeric

Pertaining to a character set that contains letters and digits. (An alpha-numeric character set includes the numerals 0 through 9, and the 26 letters of the English-language alphabet.)

Alternative Submission

A safety-report submission  via phone, walk-in, fax, email, mail or portable media; any submission through a method other than electronic (internet) use of the Safety Reporting Portal.

Animal Drug

A finished dosage form (for example, tablet, capsule, or solution) that contains a drug substance, generally, but not necessarily, in association with one or more other ingredients, intended for animal use.

Animal Feed

An article which is intended for use for food for animals other than man and which is intended for use as a substantial source of nutrients in the diet of the animal. (It is not limited to a mixture intended to be the sole ration of the animal.)

Antibiotic Drug

A substance, such as penicillin or streptomycin, produced by or derived from certain fungi, bacterial, and other organisms, that can destroy or inhibit the growth of other microorganisms. Antibiotics are widely used in the prevention and treatment of infectious diseases.

Assistive technology

Any item, piece of equipment, or system, whether acquired commercially, modified, or customized, that is commonly used to increase, maintain, or improve functional capabilities of individuals with disabilities.

Attachment

A document provided to support the complaint/adverse event such as copies of  x-rays, lab reports, scanned images of product labels and barcodes.



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