FDA Data Element Number. None.
CDER Data Element Number. C-DRG-00901
Data Element Name. Phase 4 Commitment Category
Description. This standard provides for all Phase 4 study commitment categories. Phase 4 studies are post-marketing studies that are imposed upon a pharmaceutical firm as a condition for drug approval. Defining the various commitment categories of these studies will permit CDER management to determine trend analysis.
Source. CDER Supervisory Project Managers.
Relationship. Phase 4 Fullfilment Category.
FDA Specifications. None.
CDER Specifications. Phase 4 Commitment Category shall consist of an alphabetic term which has a maximum length restricted to 60 characters, with the comma and hyphen being the only punctuation permissible. Codes representing these Phase 4 Commitment Categories shall consist of three digits.
FDA Approved Date. None.
CDER Approved Date. September 12, 1995.
FDA Revised Date.
CDER Revised Date. December 12, 1995; February 13, 1996, October 4, 1996
|A study that focuses upon a specific adverse drug experience or a specific drug toxicity in a defined patient population.
|A study of overall adverse drug experience where no specific adverse drug experience or specific drug toxicity is being investigated in a defined patient population.
|Any study where animals instead of humans are used.
|A study to determine the extent to which an active ingredient of a drug dosage form become available at the site of drug action or in a biological medium believed to reflect accessibility to a site of action.
|A study to determine whether the pharmacokinetics of a drug product is statistically distinguishable from that of another drug product with the same active ingredients.
|A study to determine the propensity of a drug to produce or exacerbate tumors or cancer cells in humans or animals, including the Asix month modified mouse study.
|CMC Method Development or Improvement
|A study to determine whether a drug or drug product's chemisty, manufacturing, or controls can be alternatively developed or improved upon.
|An in vitro study to determine the characteristics of how a drug product dissolves.
|A study designed to establish whether or not proportionate increases in the dose of a drug product are reflected in proportionate increases in pharmacokinetic parameters (i.e., AUC and CMAX).
|A study to determine the clinical differences (including pharmacodynamic studies) and similarities between drugs.
|A study to determine interactions between drugs (including pharmacokinetic and pharmacodynamic interactions, as well as cellular interactions).
|A study to determine the interactions between drugs and food (including how the pharmacokinetics of a drug are affected by food).
|A study to determine a drug's efficacy.
|A study to determine a drug's efficacy over a longer period of time than had been studied previously.
|Efficacy, New Indication
|A study to determine a drug's efficacy for an indication other than that for which it is currently approved.
|Efficacy, Subpart H
|A study to determine a drug's efficacy under Subpart H (21CFR 314.500 - 21CFR 314.560), which has been established in order to accelerate a drug's approval for serious or life-threatening illnesses.
|Any study where humans instead of animals are used.
|A study to identify impurities in the drug product.
|A survey of the literature to identify applicable books and journal articles.
|A study to determine whether a drug has the potential or ability to cause a mutation in a gene, tissue, organ, or appendage, usually by conducting microbial, insect, mammalian cell, and whole animal tests.
|Any study not included in other categories.
|A study to determine the kinetic mechanisms of exogenous drug absorption, distribution, biotransformation, release, transport, uptake, and elimination as a function of dosage, and extent and rate of metabolic processes. The study may also include measurement of the drug's effect upon the body in relation to the concentration time curve
|Reproductive Effects, Pregnancy
|A human study designed to captureand evaluate birth outcomes in women exposed to marketed drugs during pregnancy.
|A human study to determine the effect of a drug on reproduction (including, but not necessarily limited to, libido, copulation, ovulation, ovogenesis, and spermatogenesis).
|Special Population, Adolscents
|A study to determine a drug's effectiveness or safety in humans from 12 years up to 16 years of age.
|Special Population, Children
|A study to determine a drug's effectiveness or safety in humans from 2 years up to 12 years of age.
|Special Population, Elderly
|A study to determine a drug's effectiveness or safety in humans 65 years of age or older.
|Special Population, Female
|A study to determine a drug's effectiveness or safety in humans of the female gender.
|Special Population, Infants
|A study to determine a drug's effectiveness or safety in humans from one month up to 2 years of age.
|Special Population, Male
|A study to determine a drug's effectiveness or safety in humans of the male gender.
|Special Population, Neonates
|A study to determine a drug's effectiveness or safety in humans from birth up to one month of age.
|Special Population, Other
|A study to determine a drug's effect in humans having a particular characteristic (e.g., G6PD deficiency, AIDS, renal failure) not already defined.
|Special Population, Race/ Ethnicity
|A study to determine a drug's effectiveness or safety in humans of a particular race or ethnicity.
|A study over time to determine the propensity of a drug to undergo a chemical or physical change.
|A study to determine whether a drug can cause physical defects in a developing embryo.