Regulatory Operations Terms (32)

A US NDA pathway that relies, at least in part, on FDA's findings of safety and effectiveness for a previously approved drug or published literature.

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.

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

A biological product highly similar to an FDA-approved reference biologic with no clinically meaningful differences in safety, purity, and potency.

A higher regulatory designation than biosimilarity, requiring demonstration that a biosimilar can be substituted for its reference product without intervention from the prescribing physician.

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

A regulatory submission to EU or non-US authorities seeking authorization to conduct a clinical trial of an investigational medicinal product.

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.

The pathway for patients with serious or immediately life-threatening diseases to access investigational medical products outside of clinical trials.

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.

FDA-granted periods during which generic or biosimilar competition is delayed for certain approved drugs and biologics.

The formal application to the European Medicines Agency or EU national authorities seeking authorization to market a medicinal product in the EU.

FDA's 5-year marketing exclusivity for the first approval of a drug containing a novel active moiety.

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

FDA's publication identifying drug products approved on the basis of safety and effectiveness with associated therapeutic equivalence evaluations.

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

A six-month extension of existing market exclusivity and patent terms granted by FDA in return for completing pediatric studies requested by the agency.

The EU regulatory requirement for sponsors to submit a plan for pediatric development of a medicinal product to EMA's Paediatric Committee.

The FDA-required plan for pediatric development of a drug or biologic, submitted as part of NDA and BLA applications.

A study or clinical trial that a sponsor has agreed to conduct as a commitment to FDA but is not required by statute or regulation.

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.

FDA's database of biological products licensed under the Public Health Service Act, including originator biologics and biosimilars.

An FDA-approved drug product identified in the Orange Book that a generic drug sponsor relies on for an Abbreviated New Drug Application.

FDA's decision not to accept a drug or biologic marketing application for substantive review due to administrative or content deficiencies.