Regulatory Operations Terms (26)

An application for FDA approval of a generic drug product that references an already-approved drug.

An FDA pathway allowing earlier approval based on surrogate or intermediate endpoints for serious conditions.

A yearly report submitted to FDA summarizing changes and updates to an approved drug application.

Approval LETTER shapes how sponsors structure filings, amendments, and authority responses.

A submission to the FDA requesting approval to market a biological product in the United States.

An FDA designation for drugs showing substantial improvement over existing treatments for serious conditions.

CBER is the FDA center responsible for regulating vaccines, blood products, and certain cellular and gene therapy products.

CDER is the FDA center responsible for evaluating and regulating prescription and over-the-counter human drugs in the United States.

An internationally harmonized format for organizing pharmaceutical regulatory submissions into five standardized modules.

An FDA letter indicating that an application review is complete but the application is not approved as submitted.

A confidential document submitted to FDA containing detailed information about manufacturing facilities, processes, or components.

A standardized electronic format for organizing and submitting regulatory applications to health authorities worldwide.

An FDA program designed to facilitate development and expedite review of drugs treating serious conditions and filling unmet medical needs.

An application to the FDA to begin clinical trials of a new drug in humans.

MODULE 1 shapes how sponsors structure filings, amendments, and authority responses.

MODULE 2 is a core concept in dossier strategy, review-cycle management, and agency communication.

MODULE 3 is used to improve submission readiness and reduce review-cycle friction.

MODULE 4 shapes how sponsors structure filings, amendments, and authority responses.

MODULE 5 is a core concept in dossier strategy, review-cycle management, and agency communication.

A formal request to the FDA for approval to market a new pharmaceutical drug in the United States.

A status granted to drugs intended to treat rare diseases affecting fewer than 200,000 people in the US.

POST Approval STUDY is a core concept in dossier strategy, review-cycle management, and agency communication.

A meeting with FDA to discuss regulatory questions before submitting a marketing application.

US legislation that allows the FDA to collect fees from drug manufacturers to fund the new drug approval process.

An FDA designation that reduces the review time for drugs treating serious conditions and providing significant improvement over available therapy.

TYPE B Meeting is a core concept in dossier strategy, review-cycle management, and agency communication.