Drugs

PACT Commitment Category

FDA Data Element Number. None.

CDER Data Element Number. C-DRG-00919

Version Number. 001

Data Element Name. PACT Commitment Category

Description. This standard provides for all PACT study commitment categories. PACT studies are post-marketing studies for the Office of Generic Drug Products 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. Office of Generic Drug Products.

Relationship. PACT Fullfilment Category.

FDA Specifications. None.

CDER Specifications. PACT 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 PACT Commitment Categories shall consist of three digits.

FDA Approved Date. None.

CDER Approved Date. January 21, 2000.

FDA Revised Date.

CDER Revised Date.

Data Values.

NAME DEFINITION FDA CODE
Bioequivalence 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. 005
Dissolution An in vitro study to determine the characteristics of how a drug product dissolves. 008
Special Population, Pediatric A study to determine a drug's effectiveness or safety in humans from birth up to 16 years of age. 036
Stability A study over time to determine the propensity of a drug to undergo a chemical or physical change. 025
Methods validation of sample A study to determine the analysis of non-compendial products. 037

 

Page Last Updated: 12/10/2014
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