Regulated Product Submission Reporting Terminology

Preferred Label : Regulated Product Submission Reporting Terminology;

NCIt synonyms : RPS Terminology;

Details

Origin ID

C96962;

UMLS CUI

C3273144;

Semantic type(s)
- Intellectual Product [UMLS semantic type]
subset_includes_concept
- Adventitious Agents Safety Evaluation [Name, Dosage Form, Manufacturer] [NCIt concept]
- Advertisements and Promotional Labeling Transmittal: FDA Form 2253 [NCIt concept]
- Analytical Methods and Validation Reports [NCIt concept]
- Annotated Comparison With Listed Drug [NCIt concept]
- Annotated Draft Labeling Text [NCIt concept]
- Annual Report Transmittal: FDA Form 2252 [NCIt concept]
- Appendices: Novel Excipients [NCIt concept]
- Appendices: Regional Information [NCIt concept]
- Application Form: FDA Form 1571 [NCIt concept]
- Application Form: FDA Form 356h [NCIt concept]
- Approved Labeling Text for Listed Drug [NCIt concept]
- Basis for Submission Statement [NCIt concept]
- Bioavailability (BA) Study Reports and Related Information [NCIt concept]
- Body of Data [NCIt concept]
- Body of Data: Appendices [NCIt concept]
- Body of Data: Drug Product [Name, Dosage Form, Manufacturer] [NCIt concept]
- Body of Data: Drug Substance [Name, Manufacturer] [NCIt concept]
- Carcinogenicity: Long Term Studies [Species] [NCIt concept]
- Carcinogenicity: Other Studies [NCIt concept]
- Carcinogenicity: Short or Medium Term Studies [NCIt concept]
- Change in Contact/Agent [NCIt concept]
- Change in Ownership of an Application [NCIt concept]
- Change in Sponsor [NCIt concept]
- Change of Address or Corporate Name [NCIt concept]
- Characterization: Impurities [NCIt concept]
- Clinical Overview [NCIt concept]
- Clinical Summary [NCIt concept]
- Clinical Summary: References [NCIt concept]
- Clinical Trial Regulatory Authority Decision Documentation [NCIt concept]
- Clinical Trial Reports and Related Information Documentation [NCIt concept]
- Comparative BA and Bioequivalence (BE) Study Reports and Related Information [NCIt concept]
- Comparison of Generic Drug and Reference Listed Drug [NCIt concept]
- Contact/Sponsor/Applicant Information [NCIt concept]
- Control of Drug Product [NCIt concept]
- Control of Drug Product: Analytical Procedures [NCIt concept]
- Control of Drug Product: Batch Analyses [NCIt concept]
- Control of Drug Product: Characterization of Impurities [NCIt concept]
- Control of Drug Product: Justification of Specification(s) [NCIt concept]
- Control of Drug Product: Specification(s) [NCIt concept]
- Control of Drug Product: Validation of Analytical Procedures [NCIt concept]
- Control of Drug Substance [NCIt concept]
- Control of Drug Substance: Analytical Procedures [NCIt concept]
- Control of Drug Substance: Batch Analyses [NCIt concept]
- Control of Drug Substance: Justification of Specification [NCIt concept]
- Control of Drug Substance: Specification [NCIt concept]
- Control of Drug Substance: Validation of Analytical Procedures [NCIt concept]
- Control of Excipients [Name] [NCIt concept]
- Control of Excipients: Analytical Procedures [NCIt concept]
- Control of Excipients: Justification of Specifications [NCIt concept]
- Control of Excipients: Novel Excipients [NCIt concept]
- Control of Excipients: Specification(s) [NCIt concept]
- Control of Excipients: Validation of Analytical Procedures [NCIt concept]
- Correspondence Regarding Exception from Informed Consent for Research [NCIt concept]
- Correspondence Regarding Meetings [NCIt concept]
- Correspondence Related to Dispute Resolution [NCIt concept]
- Cross Reference to Other Applications [NCIt concept]
- Debarment Certification [NCIt concept]
- Description and Composition of the Drug Product [NCIt concept]
- Dispute Resolution [NCIt concept]
- Distribution Data [NCIt concept]
- Draft Carton and Container Labels [NCIt concept]
- Draft Labeling Text [NCIt concept]
- Drug Product: Container Closure System [NCIt concept]
- Drug Product: Controls of Critical Steps and Intermediates [NCIt concept]
- Drug Product: Description of Manufacturing Process and Process Controls [NCIt concept]
- Drug Product: Manufacture [NCIt concept]
- Drug Product: Manufacturer(s) [NCIt concept]
- Drug Product: Pharmaceutical Development [NCIt concept]
- Drug Product: Post-Approval Stability Protocol and Stability Commitment [NCIt concept]
- Drug Product: Process Validation and/or Evaluation [NCIt concept]
- Drug Product: Reference Standards or Materials [NCIt concept]
- Drug Product: Stability [NCIt concept]
- Drug Product: Stability Data [NCIt concept]
- Drug Product: Stability Summary and Conclusion [NCIt concept]
- Drug Substance: Characterization [NCIt concept]
- Drug Substance: Container Closure Systems [NCIt concept]
- Drug Substance: Control of Materials [NCIt concept]
- Drug Substance: Controls of Critical Steps and Intermediates [NCIt concept]
- Drug Substance: Description of Manufacturing Process and Process Controls [NCIt concept]
- Drug Substance: General Information [NCIt concept]
- Drug Substance: General Properties [NCIt concept]
- Drug Substance: Manufacture [NCIt concept]
- Drug Substance: Manufacturer(s) [NCIt concept]
- Drug Substance: Nomenclature [NCIt concept]
- Drug Substance: Post Approval Stability Protocol and Stability Commitment [NCIt concept]
- Drug Substance: Process Validation and/or Evaluation [NCIt concept]
- Drug Substance: Reference Standards or Materials [NCIt concept]
- Drug Substance: Stability [NCIt concept]
- Drug Substance: Stability Data [NCIt concept]
- Drug Substance: Stability Summary and Conclusions [NCIt concept]
- Drug Substance: Structure [NCIt concept]
- Efficacy Information Amendment [NCIt concept]
- Efficacy Supplement [NCIt concept]
- Elucidation of Structure and Other Characteristics [NCIt concept]
- Excipients of Human or Animal Origin [NCIt concept]
- Exclusivity Request [NCIt concept]
- Exemption from Informed Consent for Research [NCIt concept]
- Extrinsic Factor Study Reports and Related Information [NCIt concept]
- Facilities and Equipment [Name, Manufacturer] [NCIt concept]
- Fast Track Designation Request [NCIt concept]
- Fast Track Designation Withdrawal Request [NCIt concept]
- Field Alert Reports [NCIt concept]
- Field Copy Certification [NCIt concept]
- Final Carton or Container Labels [NCIt concept]
- Final Labeling [NCIt concept]
- Final Labeling Text [NCIt concept]
- Final Package Insert (Package Inserts, Patient Information, Medication Guides) [NCIt concept]
- Financial Certification and Disclosure [NCIt concept]
- Foreign Labeling [NCIt concept]
- Foreign Marketing History [NCIt concept]
- General Investigational Plan [NCIt concept]
- Generic Drug Enforcement Act Statement [NCIt concept]
- Genotoxicity: In Vitro [NCIt concept]
- Genotoxicity: In Vivo [NCIt concept]
- Healthy Subject PD and PK/PD Study Reports and Related Information [NCIt concept]
- Healthy Subject PK and Initial Tolerability Study Reports and Related Information [NCIt concept]
- In Vitro - In Vivo Correlation Study Reports and Related Information [NCIt concept]
- Inactivation Request [NCIt concept]
- Individual Study Information [NCIt concept]
- Information Amendment: Information Not Covered Under Modules 2 to 5 [NCIt concept]
- Intrinsic Factor PK Study Reports and Related Information [NCIt concept]
- Introduction to Summary [NCIt concept]
- Investigational Brochure [NCIt concept]
- Investigational Drug Labeling [NCIt concept]
- Label Comprehension Studies [NCIt concept]
- Labeling History [NCIt concept]
- Labeling Text for Reference Listed Drug [NCIt concept]
- Labeling: Draft Labeling [NCIt concept]
- Labeling: Investigational Drug Labeling [NCIt concept]
- List of Authorized Persons to Incorporate by Reference [NCIt concept]
- Listed Drug Labeling [NCIt concept]
- Log of Outstanding Regulatory Business [NCIt concept]
- Manufacture: Batch Formula [NCIt concept]
- Manufacturing Process Development [NCIt concept]
- Meeting Background Materials [NCIt concept]
- Meeting Request [NCIt concept]
- Module 1 Administrative Information [NCIt concept]
- Module 1: Administrative Information [NCIt concept]
- Module 1: Annual Report [NCIt concept]
- Module 1: Application Status [NCIt concept]
- Module 1: Cover Letters [NCIt concept]
- Module 1: Fast Track [NCIt concept]
- Module 1: Forms [NCIt concept]
- Module 1: Labeling [NCIt concept]
- Module 1: Meetings [NCIt concept]
- Module 1: Other Correspondence [NCIt concept]
- Module 1: References [NCIt concept]
- Module 2 Summaries [NCIt concept]
- Module 3 Quality [NCIt concept]
- Module 3: Literature References [NCIt concept]
- Module 4 Nonclinical Study Reports [NCIt concept]
- Module 4: Literature References [NCIt concept]
- Module 4: Pharmacology [NCIt concept]
- Module 4: Study Reports [NCIt concept]
- Module 5 Clinical Study Reports [NCIt concept]
- Module 5: Literature References [NCIt concept]
- Nonclinical Overview [NCIt concept]
- Nonclinical Written and Tabulated Summaries [NCIt concept]
- Nonclinical Written and Tabulated Summaries: Introduction [NCIt concept]
- Notification of Charging Under Treatment IND [NCIt concept]
- Notification of Discontinuation of Clinical Trial [NCIt concept]
- Other Correspondence Regarding Pediatric Exclusivity or Study Plans [NCIt concept]
- Other Correspondence: Environmental Analysis [NCIt concept]
- Other Methods Validation Information [NCIt concept]
- Other Pharmacokinetic Studies [NCIt concept]
- Other Toxicity Studies: Antigenicity [NCIt concept]
- Other Toxicity Studies: Dependence [NCIt concept]
- Other Toxicity Studies: Immunotoxicity [NCIt concept]
- Other Toxicity Studies: Impurities [NCIt concept]
- Other Toxicity Studies: Mechanistic Studies [NCIt concept]
- Other Toxicity Studies: Metabolites [NCIt concept]
- Other Toxicity Studies: Other [NCIt concept]
- Patent Certification [NCIt concept]
- Patent Information [NCIt concept]
- Patent and Exclusivity [NCIt concept]
- Patient PD and PK/PD Study Reports and Related Information [NCIt concept]
- Patient PK and Initial Tolerability Study Reports and Related Information [NCIt concept]
- Pediatric Administrative Information [NCIt concept]
- Pharmacokinetic Tabulated Summary [NCIt concept]
- Pharmacokinetic Written Summary [NCIt concept]
- Pharmacokinetics: Absorption [NCIt concept]
- Pharmacokinetics: Distribution [NCIt concept]
- Pharmacokinetics: Drug Interactions [NCIt concept]
- Pharmacokinetics: Excretion [NCIt concept]
- Pharmacokinetics: Metabolism [NCIt concept]
- Pharmacology Tabulated Summary [NCIt concept]
- Pharmacology Written Summary [NCIt concept]
- Pharmacology: Pharmacodynamic Drug Interactions [NCIt concept]
- Pharmacology: Primary Pharmacodynamics [NCIt concept]
- Pharmacology: Safety Pharmacology [NCIt concept]
- Pharmacology: Secondary Pharmacodynamics [NCIt concept]
- Plasma Protein Binding Study Reports and Related Information [NCIt concept]
- Population PK Study Reports and Related Information [NCIt concept]
- Pre IND Correspondence [NCIt concept]
- Promotional Material Document [NCIt concept]
- Proposal for Written Agreement [NCIt concept]
- Proposed Pediatric Study Request and Amendments [NCIt concept]
- Public Disclosure Statement for Exception from Informed Consent for Research [NCIt concept]
- Quality Information Amendment [NCIt concept]
- Quality Overall Summary [NCIt concept]
- Reactivation Request [NCIt concept]
- Regulated Product Submission Reporting [NCIt concept]
- Reinstatement Request [NCIt concept]
- Reports of Analyses of Data from More Than One Study [NCIt concept]
- Reports of Bioanalytical and Analytical Methods for Human Studies [NCIt concept]
- Reports of Biopharmaceutic Studies [NCIt concept]
- Reports of Efficacy and Safety Studies [Indication] [NCIt concept]
- Reports of Efficacy and Safety Studies: Other Study Reports and Related Information [NCIt concept]
- Reports of Hepatic Metabolism and Drug Interaction Studies [NCIt concept]
- Reports of Human Pharmacodynamic (PD) Studies [NCIt concept]
- Reports of Human Pharmacokinetic (PK) Studies [NCIt concept]
- Reports of Postmarketing Experience [NCIt concept]
- Reports of Studies Pertinent to Pharmacokinetics Using Human Biomaterials [NCIt concept]
- Reports of Studies Using Other Human Biomaterials [NCIt concept]
- Reproductive and Developmental Toxicity: Embryofetal Development [NCIt concept]
- Reproductive and Developmental Toxicity: Fertility and Early Embryonic Development [NCIt concept]
- Reproductive and Developmental Toxicity: Prenatal and Postnatal Development Including Maternal Function [NCIt concept]
- Request for Comments and Advice [NCIt concept]
- Request for Deferral of Pediatric Studies [NCIt concept]
- Request for Dispute Resolution [NCIt concept]
- Request for Pediatric Exclusivity Determination [NCIt concept]
- Request for Waiver for In Vivo Studies [NCIt concept]
- Request for Waiver of In Vivo Bioavailability Studies [NCIt concept]
- Request for Waiver of Pediatric Studies [NCIt concept]
- Request for Withdrawal of Application Approval [NCIt concept]
- Request for a Waiver [NCIt concept]
- Request to Charge [NCIt concept]
- Risk Management Plans [NCIt concept]
- Rolling Review Request [NCIt concept]
- Safety Information Amendment [NCIt concept]
- Special Protocol Assessment Request [NCIt concept]
- Special Protocol Assessment Request: Carcinogenicity Study [NCIt concept]
- Special Protocol Assessment Request: Clinical Study [NCIt concept]
- Special Protocol Assessment Request: Stability Study [NCIt concept]
- Statement of Right of Reference [NCIt concept]
- Status of Other Postmarketing Studies [NCIt concept]
- Status of Postmarketing Study Commitments [NCIt concept]
- Studies in which the Offspring (Juvenile Animals) are Dosed and/or Further Evaluated [NCIt concept]
- Study Reports and Related Information of Controlled Clinical Studies Pertinent to the Claimed Indication [Type of Control] [NCIt concept]
- Study Reports and Related Information of Uncontrolled Clinical Studies [NCIt concept]
- Study Reports: Pharmacokinetics [NCIt concept]
- Study Reports: Toxicology [NCIt concept]
- Summary for Nonclinical Studies [NCIt concept]
- Summary of Biopharmaceutic Studies and Associated Analytical Methods [NCIt concept]
- Summary of Clinical Efficacy [Indication] [NCIt concept]
- Summary of Clinical Pharmacology Information [NCIt concept]
- Summary of Clinical Pharmacology Studies [NCIt concept]
- Summary of Clinical Safety [NCIt concept]
- Summary of Labeling Changes [NCIt concept]
- Summary of Manufacturing Changes [NCIt concept]
- Summary of Microbiological Changes [NCIt concept]
- Summary of Other Significant New Information [NCIt concept]
- Summary of Safety Information [NCIt concept]
- Synopsis of Individual Studies [NCIt concept]
- Tabular Listing of all Clinical Studies [NCIt concept]
- Toxicology Tabulated Summary [NCIt concept]
- Toxicology Written Summary [NCIt concept]
- Toxicology: Carcinogenicity [NCIt concept]
- Toxicology: Genotoxicity [NCIt concept]
- Toxicology: Local Tolerance [NCIt concept]
- Toxicology: Other Toxicity Studies [NCIt concept]
- Toxicology: Repeat Dose Toxicity [Species, Route, Duration] [NCIt concept]
- Toxicology: Reproductive and Developmental Toxicity [NCIt concept]
- Toxicology: Single Dose Toxicity [Species and Route] [NCIt concept]
- Transfer of Obligation [NCIt concept]
- Transmittal of Labels and Circulars: FDA Form 2567 [NCIt concept]
- User Fee Cover Sheet: FDA Form 3397 [NCIt concept]
- Validation Characteristics [NCIt concept]
- Withdrawal Request [NCIt concept]
- Withdrawal of Listed Drug [NCIt concept]
- Withdrawal of an Unapproved NDA [NCIt concept]

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