New & Updated Terms

FDA regulations governing electronic records and electronic signatures to ensure their trustworthiness and reliability.

A premarket submission demonstrating that a medical device is substantially equivalent to a legally marketed predicate device.

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.

The substance in a pharmaceutical drug that is biologically active and produces the intended therapeutic effect.

Any untoward medical occurrence in a patient or clinical trial subject administered a pharmaceutical product.

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

A comprehensive document containing all information and instructions for manufacturing a specific batch of drug product.

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.

The section of a regulatory submission describing a drug's composition, manufacturing process, and quality controls.

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 company that provides outsourced research services to pharmaceutical and biotechnology companies.

A systematic approach to identifying, investigating, and addressing the root causes of quality problems.

The completeness, consistency, and accuracy of data throughout its lifecycle, following ALCOA+ principles.

A pathway for novel low-to-moderate risk medical devices that lack a predicate but do not require PMA-level review.

Systematic practices applied during product design and development to ensure devices meet user needs and intended uses.

A departure from an approved procedure, specification, or established standard during manufacturing or testing.

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 European Union agency responsible for the scientific evaluation, supervision, and safety monitoring of medicines.

An inactive substance used as a carrier or vehicle for the active pharmaceutical ingredient in a drug product.

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

The US federal agency responsible for protecting public health by regulating food, drugs, biologics, medical devices, and cosmetics.

International ethical and scientific quality standards for designing, conducting, and reporting clinical trials.

Regulations ensuring pharmaceutical products are consistently produced and controlled according to quality standards.

Canada's federal department responsible for regulating drugs, medical devices, and other health products.

The process by which a research participant learns about and agrees to participate in a clinical trial after understanding the risks, benefits, and alternatives.

An independent committee that reviews and approves research involving human subjects to ensure ethical standards and participant protection.

A global organization that develops harmonized pharmaceutical guidelines to ensure drug quality, safety, and efficacy.

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

All written, printed, or graphic matter on or accompanying a drug or device, including the package insert and promotional materials.

FDA mandatory reporting requirements for manufacturers and user facilities when medical devices may have caused or contributed to death or serious injury.

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.

A test result that falls outside the established acceptance criteria or specifications.

A periodic safety report format harmonized by ICH for presenting comprehensive benefit-risk analysis of medicinal products.

A periodic report summarizing the global safety profile of a marketed medicinal product.

Japan's regulatory agency responsible for approving pharmaceuticals, medical devices, and regenerative products.

The science and activities relating to the detection, assessment, understanding, and prevention of adverse drug reactions.

The first stage of clinical testing in humans, primarily assessing safety, tolerability, and pharmacokinetics.

Clinical trials evaluating a drug's efficacy and optimal dosing in patients with the target disease.

Large-scale pivotal trials that confirm a drug's efficacy and safety to support regulatory approval.

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

The FDA process for approving Class III high-risk medical devices based on clinical evidence of safety and effectiveness.

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.

Documented evidence establishing high confidence that a process consistently produces a product meeting specifications.

Documented evidence that a process consistently produces a product meeting predetermined specifications and quality attributes.

A systematic approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding.

FDA regulations governing the methods and facilities used in the manufacture of medical devices.

A drug safety program required by FDA for certain medications with serious safety concerns to ensure benefits outweigh risks.

A document describing safety activities to identify, characterize, prevent, and minimize risks relating to medicinal products.

An adverse event that results in death, is life-threatening, requires hospitalization, causes disability, or is a congenital anomaly.

The process of identifying new or changing safety information from pharmacovigilance data that may require further investigation.

Testing to determine how a drug product's quality changes over time under the influence of environmental factors.

Australia's regulatory agency for therapeutic goods including prescription medicines, medical devices, and biologicals.

A system for identifying medical devices through their distribution and use using a unique numeric or alphanumeric code.

An official FDA notice of significant regulatory violations requiring prompt corrective action.