6 Questions
Which application type does the FDA review in connection with the technical contents of Drug Master Files (DMFs)?
INDs
What is the purpose of an ANDA (Abbreviated New Drug Application) in the pharmaceutical industry?
To gain approval to market a generic drug in the U.S.
What is the purpose of a Drug Master File (DMF) according to the text?
To allow parties to reference material without disclosing DMF contents
What does NDA stand for in the context of drug application?
New Drug Application
What does BLA stand for in the context of drug application?
Biologics License Application
What is the purpose of an IND (Investigational New Drug) application in the pharmaceutical industry?
To obtain permission from the FDA to conduct clinical trials
Study Notes
FDA Review and Applications
- The FDA reviews Type II API (Active Pharmaceutical Ingredient) DMFs in connection with their technical contents.
Drug Applications
- An ANDA (Abbreviated New Drug Application) is a type of application that allows a generic drug manufacturer to seek approval for a generic equivalent of a drug that has already been approved by the FDA.
DMF Purpose
- A Drug Master File (DMF) is a document that contains confidential and proprietary information about a drug substance, excipient, or drug product.
Acronyms and Applications
- NDA stands for New Drug Application, which is a type of application submitted to the FDA to seek approval for a new drug.
- BLA stands for Biologics License Application, which is a type of application submitted to the FDA to seek approval for a biologic product.
IND Application
- The purpose of an IND (Investigational New Drug) application is to seek permission from the FDA to begin human clinical trials with a new drug or biologic product.
Test your knowledge of frequently used terms related to FDA drug applications and regulations. This quiz covers terms such as NDA, ANDA, IND, BLA, CBER, CDER, CFR, PDR, BF, BMR, BPR, MFR, COA, and Drug Master File.
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