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CDER Data Standards Manual

The CDER Data Standards Manual (DSM) is a compilation of standardized nomenclature monographs that have been reviewed and approved by the CDER Nomenclature Standards Committee (NSC). These CDER nomenclature standards are considered binding upon all new automated databases, and upon all existing automated databases when undergoing a major redesign. Use of the nomenclature standards are strictly voluntary for static existing databases. Some of the current CDER automated databases that use these nomenclature standards include the Center-wide Oracle Management Information System (COMIS), the Division Files System (DFS), the Drug Product Reference File (DPRF), the Drug Registration and Listing System (DRLS), the Developers and Distributors System (DADS), the Special Products On-Line Tracking System (SPOTS), and the Phase 4 Tracking System.

The DSM is modeled after the Agency Data Standards Manual in format and content. Several of DSM monographs for CDER have been jointly developed by the NSC and the Agency Data Standards Committee, which is represented by each of the Centers, as well as OC and ORA. DSM monographs may have been derived either wholly or in part from other nomenclature standards settings bodies, as well, such as the International Conference on Harmonization (ICH), the United States Pharmacopeia (USP), the United States Adopted Names Council (USAN), the American Hospital Formulary Service (AHFS), the Chemical Abstracts Service (CAS), the National Institutes of Standards and Technology (NIST), the International Organization for Standardization (ISO), the American Society for Testing and Materials (ASTM), US Census Bureau, US Postal Service, and the Central Intelligence Agency.

The NSC meets quarterly to discuss proposed additions and changes to the DSM. If you have any questions about the DSM or the NSC, or would like to propose a change or addition to one of the DSM monographs, please contact William A. Hess at 301-827-3281 or hess@cder.fda.gov.
Authority

Monograph Number

MaPP 7600.4 Nomenclature Standards Committee

7600.4

 

 

 

CDER Nomenclature Control Policies

Monograph Number
Implementation Policy C-POL-00001
Valid Values Policy C-POL-00002
Center-wide Thesauri, Dictionaries, and Tables Policy C-POL-00003
Metric System and Potency Expression Policy C-POL-00004
Use of Drug Name Terms Policy C-POL-00005

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Drug Nomenclature Monographs

Monograph Number
Drug Classification C-DRG-00101
Dosage Form C-DRG-00201
Route of Administration C-DRG-00301
Ingredient Name C-DRG-00401
Proprietary Name C-DRG-00402
Animal Common Names C-DRG-00403
Animal Cell Tissue Fluid Biomolecule C-DRG-00404
Biotechnology Origin C-DRG-00405
Potency C-DRG-00501
Indications C-DRG-00601
Therapeutic Equivalence Code C-DRG-00701
Phase 4 Commitment Category C-DRG-00901
Phase 4 Fulfillment Category C-DRG-00902
Pediatric use Supplement Rule C-DRG-00903
Pediatric Use Supplement Clinical Efficacy Trials Category C-DRG-00904
Pediatric Use Supplement PK/PD Category C-DRG-00905
Pediatric Use Supplement Safety/Adverse Reaction Category C-DRG-00906

Package Type

C-DRG-00907

Pediatric Exclusivity Study Type

C-DRG-00908

Pediatric Exclusivity Study Age Group

C-DRG-00909

Pediatric Exclusivity Study Basis

C-DRG-00910

Pediatric Exclusivity Study Drug List

C-DRG-00911

Geriatric Use Supplement Rule

C-DRG-00913

Geriatric Use Supplement Clinical Efficacy Trials Category

C-DRG-00914

Geriatric Use Supplement PK/PD Category

C-DRG-00915

Geriatric Use Supplement Safety/Adverse Reaction Category

C-DRG-00916

Industry Meeting Type

C-DRG-00917

Industry Meeting Response

C-DRG-00918

PACT Commitment Category

C-DRG-00919

PACT Fulfillment Category

C-DRG-00920

Global Suplement Status

C-DRG-00921

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General Nomenclature Monographs Monograph Number
Calendar Date - Format 2 C-GEN-00002
Fiscal Year C-GEN-00005
Person Given Name C-GEN-00201
Person Middle Name C-GEN-00202
Person Surname C-GEN-00203
Person Family Rank C-GEN-00204
Sponsor/Applicant Name C-GEN-10201
Telephone Area Code C-GEN-10202
Telephone Country Code C-GEN-10203
Telephone Number, Format 1 C-GEN-10204
Telephone Number, Format 2 C-GEN-10205
Telephone City Code C-GEN-10206
Application Type C-GEN-10207
Application Number C-GEN-10208
Gender C-GEN-10209
Race C-GEN-10210
Marital Status C-GEN-10211
Height C-GEN-10212
Weight C-GEN-10213
Educational Level C-GEN-10301
ECH Document Type C-GEN-10302
FYI Copy Destination C-GEN-10303
Media Type C-GEN-10304
Plant Type C-GEN-10305
DFS Recommendation Code C-GEN-10306

INVAS Volume Type

C-GEN-10307

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Geographic Nomenclature Monographs Monograph Number
Countries, Dependencies, and Areas of Special Sovereignty C-GEO-00101
States and Outlying Areas of the United States C-GEO-00204
Street Address C-GEO-00301
City Name C-GEO-00302
State/Foreign Province C-GEO-00303
Country Name C-GEO-00304
District Office Code C-GEO-00305
Division of the World C-GEO-00306

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FDA/Center for Drug Evaluation and Research
Last Updated: December 11, 2002
Originator: CDER
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