US Regulations
This is an application which is filed with the US FDA to get approval for legally testing an experimental drug on human subjects in the USA
What is an Investigational New Drug (IND) application?
This center primarily regulates Chemical Products
What is Center for Drug Evaluation and Research (CDER)?
This report is required annually for investigational drugs to summarize safety data
What is a DSUR?
This application is specifically for Biologic Products?
What is Biologics License Application (BLA)?
This center primarily regulates Biological Products
What does Center of Biologics Evaluation and Research (CBER) regulate?
This is an application which is filed with the FDA to market a new pharmaceutical product for sale in USA
What is a New Drug Application (NDA)?
This form is used to submit a BLA application to the FDA
What is Form 356h?
What is the Clinical overview?
This abbreviated application is often used for generic approvals
What is ANDA?
This medicinal product is almost an identical copy of an original, marketed, biological product.
What is a biosimilar biological product?
This process involves evaluating a proposed proprietary name to prevent medication errors.
What is the proprietary name review process?
This FDA's program/form of reporting adverse events and medication errors associated with medical products
What is Medwatch?
The FDA requieres this type of plan to be submitted for drugs that might be used in pediatric populations
What is a Pediatric Study Plan (PSP)?
This FDA center is responsible for the premarket review and continuing oversight of monoclonal antibodies for in vivo use, as an example.
What is the Center for Drug Evaluation and Research (CDER)?
This term refers to a process designed by the FDA to facilitate the development and expedite the review of drugs that treat serious conditions.
What is Fast track designation?
This is submitted to provide confidential information to the FDA and is not required by law or regulations; in addition, this is not approved nor disproved by the FDA
What is a Drug Master File (DMF)?
This term refers to the marketing activities aimed at informing healthcare professionals and consumers about a drug or medical product
What is Advertising and Promotion?
This important aspect of module 4 assesses the potential adverse effects of drug based on animal studies
What is toxicology?
This acronym stands for the regulations ensuring that products are consistently produced and controlled according to quality standards.
Whay is GMP?
This term refers to changes made to the Chemistry, Manufacturing and Controls section of a drug application
What is CMC amendment?
What are quality control tests?
This document provides detailed information about an investigational product for clinical investigators
What is Investigator Brochure?
In pharmaceutical manufacturing, this term describes the active substances used to create the final product
What are active pharmaceutical ingredients (APIs)?
This term refers to a type of submission to the FDA that allows for certain changes to be implemented within 30 days
What is CBE-30?
This term refers to the FDA's order to suspend a clinical trial due to safety concerns or regulatory issues
What is a clinical hold?