Not distinguishing between uppercase (capital) letters and lowercase. (The software treats \"CaT\" just like \"cat.\")
Distinguishing between uppercase (capital) and lowercase (small) letters (e.g., the software distinguises \"CaT\" from \"cat.\")
FDA’s Center for Biologics Evaluation and Research
Biological therapeutic agents consisting of human or animal cells or derived from them.
A set of symbols and encodings (Example: an alphabet with the letters: ‘A’, and ‘B’ -- and each letter is given a number where : ‘A’ = 0, ‘B’ = 1. The letter ‘A’ is a symbol, the number ‘0’ is the encoding for ‘A’; the combination of the letters and their encodings is the character set.)
In the context of a database, this represents a data record that is linked to a parent record and cannot exist without the parent. (That is, the database will not allow creation of a child record without first creating the parent record.)
The second of five parts in an FDA product code, consisting of one alpha character, that relates to an Industry, but is more specific. The code designates the food group, source, product, use, pharmacological action, category or animal species of the product.
A controlled study involving human subjects, designed to evaluate prospectively the safety and effectiveness of new drugs or devices or of behavioral interventions.
A value, with an associated definition, that is part of a domain set of possible values for indicating a status or variable of a function.
A dye, pigment, or other substance--whether synthetic or derived from a vegetable, mineral, or other source--which imparts a color when added or applied to a food, drug, cosmetic, or the human body. Under the Federal Food, Drug, and Cosmetic Act (Chapter VII, section 721), color additives, except for coal tar hair dyes, are subject to FDA approval before they may be used in food, drugs, or cosmetics, or in medical devices that come in contact with the bodies of people or animals for a significant period of time.
[Reference: 21 CFR § 3.2(e) for the full text] (1) A product of two or more regulated components, i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or otherwise combined or mixed and produced as a single entity; (2) Two or more separate products packaged together in a single package or as a unit and comprised of drug and device products, device and biological products, or biological and drug products; (3) A drug, device, or biological product packaged separately that according to its investigational plan or proposed labeling is intended for use only with an approved individually specified drug, device, or biological product where both are required to achieve the intended use, indication, or effect . . . or (4) Any investigational drug, device, or biological product packaged separately that according to its proposed labeling is for use only with another individually specified investigational drug, device, or biological product where both are required to achieve the intended use, indication, or effect.
Refers to the primary material(s) that contact and/or hold the product. Food container materials are important because, not only do they maintain freshness, prevent damage and spoilage, but they can also contaminate the product through chemical migration, foreign objects, and so on. Common container materials are ceramic/earthenware, glass, metal, paper, plastic, etc.
\"Dictionaries\" that enforce the uses of predefined, authorized terms (as comparedthat have been pre-selected by the designer of the controlled vocabulary as opposed to natural language vocabularies where there is no restriction on the vocabulary that can be used.
Articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance. Also includes articles intended for use as a component of any such articles except that such term shall not include soap. [Refer to Sec. 201. [21 U.S.C. 321], Chapter Ii—Definitions 1]
a drug which, or the container or labeling of which, without authorization, bears the trademark, trade name, or other identifying mark, imprint, or device, or any likeness thereof, of a drug manufacturer, processor, packer, or distributor other than the person or persons who in fact manufactured, processed, packed, or distributed such drug and which thereby falsely purports or is represented to be the product of, or to have been packed or distributed by, such other drug manufacturer, processor, packer, or distributor.