Category: Glossary

Envelope

Structured information part of the eCTD module 1 specific to the product and the application information (full name, applicant, regulatory activity, type of application, procedure

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Electronic Signature

[FDA] Electronic signature means a computer data compilation of any symbol or series of symbols executed, adopted or authorized by an individual to be the

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Efficacy Supplement

[FDA] A supplement to an approved application proposing to make one or more related changes from among the following changes to product labeling: Add or

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eCTD Validation Criteria

Criteria published by various Health Authorities that define technical criteria for accepting an eCTD submission. Validation criteria may apply to XML backbones, files, folder structures

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eCTD Backbone

The Submission XML Table of Contents file which provides an interface for industry-to-agency transfer of regulatory information that takes into consideration the facilitation of the

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eCopy

An electronic version of a medical device submission created and submitted on a compact disc (CD), digital video disc (DVD), or a flash drive. For

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Drug Product (DP)

[A] finished dosage form, e.g., tablet, capsule, or solution, that contains a drug substance, generally, but not necessarily, in association with one or more other

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Dosage Strength

(1) The proportion of active drug substance to excipient, measured in units of volume or concentration.(2) The strength of a drug product, which indicates the

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Dosage Form

The physical state in which a drug is dispensed for use. For example: a frequent dosage form of procaine is a sterile solution of procaine.

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Digital Signature

An electronic signature based upon cryptographic methods of originator authentication, computed by using a set of rules and a set of parameters such that the

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Device

An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part or accessory, which is intended

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Medical Device

An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part or accessory, which is intended

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Define.xml

“Define-XML is a file tha metadata that describes any tabular dataset structure. When used with the CDISC Foundational Standards, it provides the metadata for human

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Data Listings

“Data listings are datasets in which each record is a series of observations collected foreach subject during a study or for each subject for each

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DailyMed

DailyMed contains labeling for prescription and nonprescription drugs for human and animal use, and for additional products such as medical gases, devices, cosmetics, dietary supplements,

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Core Data Sheet (CDASH)

Core Data Sheet is an unofficial working document prepared by marketing authorization holders typically containing material relating to safety, indications, dosing, pharmacology, and other information

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Complete Response Letter

[FDA] A written communication to an applicant from FDA usually describing all of the deficiencies that the agency has identified in an application or abbreviated

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Common Technical Document (CTD)

The Common Technical Document (CTD) is a format for marketing applications submitted to ICH participating regions, controlling the organization of information in an application.

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Commitment

“Activities to be performed by or on behalf of a Party or its Affiliates as a condition or in connection with receipt of Regulatory Approval

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CMC Supplement

See Manufacturing Supplement. [FDA] a supplement to an approved application which includes a change(s) to the manufacturing process, including product testing or changes to the

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Manufacturing Supplement

[FDA] a supplement to an approved application which includes a change(s) to the manufacturing process, including product testing or changes to the facility(ies) involved in

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Checksum

A checksum is a sequence of numbers and letters used to check data for errors. If the checksum of an original file is known, an

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Certificate of Suitability (CEP)

Certificate of Suitability to the monographs of the European Pharmacopoeia. A certificate that certifies compliance of the active pharmaceutical ingredients (API) or pharmaceutical ingredients with

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Centralised Procedure (CP)

“An EU Procedure type in which the EMA (European Medicines Agency) reviews and approves the application on behalf of all European Union countries.Certain drugs, such

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CE Mark (CE)

Authorisation in the European Economic Area (EEA) for the marketing and sale of devices, and specifically within Life Sciences, Medical Devices.

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Biologic Product

[FDA] FDA: A biologic product is any virus, serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product applicable to the

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Approval Letter

[FDA] A written communication to an applicant from FDA approving an application or an abbreviated application. Source: 21 CFR 314.3(b)

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Applicant

“A pharmaceutical company or its agent that is submitting information in support of an application.” Source: Harmonised Technical Guidance for eCTD Submissions in the EU

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Annual Report

[FDA] Post-NDA report (submission) providing the FDA with a summary of new research data, distribution information and labeling changes plus certain other information form manufacturers.

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Annotated ECG waveform data

“Annotated ECG waveform data are raw voltage-versus-time data comprising the electrocardiogram recording, to which have been attached the identification of various intervals or other features.”

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Analysis Datasets

Analysis datasets are datasets created to support results presented in study reports, the ISS and the ISE and to support other analyses that enable a

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Analysis Data Model (AdAM)

ADaM defines dataset and metadata standards that support efficient generation, replication, and review of clinical trial statistical analyses, and traceability among analysis results, analysis data,

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Amendment

“[FDA] Information submitted to a pending submission, including additional information or reanalysis of data previously submitted to clarify, revise or modify the application as originally

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Adjuvant

An ingredient in a medicine that increases or modifies the activity of the other ingredients. Adjuvants are often included in vaccines to enhance the body’s

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Drug Substance (DS)

[FDA] [An] active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease

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Abridged Application

Abridged applications are applications where, subject to certain conditions, the applicant is not required to provide the results of pharmacological and toxicological tests or the

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Adverse Drug Reaction (ADR)

Single or repeated drug administration as well as combination of different drugs administration can cause injury to patients. Adverse Drug Reaction: The detection, assessment, understanding

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Signal Detection

Signal detection process is a set of activities performed to determine whether, based on an examination of individual case safety reports (ICSRs), aggregated data from

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