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Terms in this set (34)
Document Archiving, Reporting, and Regulatory Tracking
Design and Development Plan
Drug Development Tools
Drug Enforcement Administration
Dear Health Care Professional (DHCP) letter
Correspondence mailed by a manufacturer and/or distributor to physicians and/or other health care professionals to convey important information about drugs or devices. DHCP letters are considered promotional labeling and may be associated with recalls or device corrections or removals. These letters can be requested by FDA or initiated by the applicant
An official action in accordance with 21 CFR 1404 to exclude a person from directly or indirectly providing sere vices in any capacity to a firm with an approved or pending drug or device product application. A debarred corporation is prohibited from submitting or assisting in the submission of any NDA or ANDA. Equivalent to disqualification for devices requiring a PMA submission.
Declaration of Helsinki
Ethical principles for medical research involving human subjects. Trials conducted under Good Clinical Practice generally follow the Declaration of Helsinki.
A court order entered when a seized article is not claimed or defended. The order condemns the article as being in tion of the law and provides for its destruction, donation to charity, sale or disposal as the court may elect to decree.
De Novo Process
Provides a route to market for low to risk medical devices, but have been classified in Class Ill because FDA has found them to be "not substantially equivalent" (NSE) to legally marketed predicate devices
Drug Efficacy Study Implementation
Device Facility User Fee
Design History File. Describes a finished device's design
Department of Health and Human Services
Device History Record. Contains a device's production history.
Drug Information Association
Discipline Review Letter
Used by FDA to convey early thoughts on possible deficiencies found by a discipline review team for its portion of the pending application at the conclusion of the discipline review.
Data Monitoring Committee
Division of Medication Error Prevention and Analysis
Drug Master File. Submission to FDA that may be used to provide confidential detailed information about facilities, processes or articles used in the manufacturing, processing, packaging and storing of one or more human drugs.
Division of Manufacturing and Product Quality (CBER)
Device Master Record. Compilation of records containing a finished device's procedures and specifications.
Division of Nonprescription Clinical Evaluation
Direct Recall Classification
Drug Registration and Listing System
Any article intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man
A searchable database of brand-name and generic prescription and OTC human drugs and biological therapeutic products approved since 1939.
"Drug Facts" Label
Labeling requirement for all nonprescription, over-the-counter (OTC) medicine labels with detailed usage and warning information so consumers can properly choose and use the products.
A finished dosage form (e.g., tablet, capsule, solution, etc.) containing an active drug ingredient. It generally, but not necessarily, also is associated with inactive ingredients. This includes a finished dosage form not containing an active ingredient but intended to be used as a placebo.
Drug Quality and Security Act. Also called the Compounding Quality Act.
Dietary Supplement Health and Education Act of 1994
Division of Small Manufacturers, International, and Consumer Assistance (CDRH)
Dietary Supplement and Nonprescription Drug Consumer Protection Act
Data Universal Numbering System. A unique nine-digit sequence provided by Dun & Bradstreet, which is specific to each physical location of an entity (e.g., branch, division and headquarter).
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