Regulatory Terms Starting With C

Center for Biologics Evaluation and Research (CBER)

The FDA center responsible for regulating biological products including vaccines, blood products, and cell and gene therapies.

Center for Devices and Radiological Health (CDRH)

The FDA center responsible for ensuring the safety and effectiveness of medical devices and radiation-emitting products.

Center for Drug Evaluation and Research (CDER)

The FDA center responsible for ensuring that drugs marketed in the United States are safe and effective.

Chemistry, Manufacturing, and Controls (CMC)

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

Class I Medical Device (Class I)

Low-risk medical devices subject to general controls and, in most cases, exempt from 510(k) premarket notification.

Class II Medical Device (Class II)

Moderate-risk medical devices subject to general controls plus special controls, typically requiring 510(k) premarket notification.

Class III Medical Device (Class III)

Highest-risk medical devices requiring Premarket Approval (PMA) based on clinical evidence of safety and effectiveness.

Clinical Hold (Clinical Hold)

An FDA order to a sponsor to delay a proposed or suspend an ongoing clinical investigation due to safety concerns or deficiencies.

Clinical Trial Application (CTA)

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

Combination Product (Combination Product)

A therapeutic product combining two or more regulated components (drug, device, biologic) with a primary mode of action determining the lead FDA center.

Common Technical Document (CTD)

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

Compendial Method (Compendial Method)

An analytical method published in an official pharmacopoeia (USP, Ph. Eur., JP) that serves as the recognized standard for testing a specific article.

Complete Response Letter (CRL)

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

Contract Research Organization (CRO)

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

Control Strategy (Control Strategy)

The planned set of controls, derived from product and process understanding, that ensures process performance and product quality.

Corrective and Preventive Action (CAPA)

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

Critical Process Parameter (CPP)

A process parameter whose variability has an impact on a Critical Quality Attribute and therefore must be monitored or controlled to ensure product quality.

Critical Quality Attribute (CQA)

A physical, chemical, biological, or microbiological property of a drug substance or product that must be within an appropriate range to ensure quality.

Current Good Manufacturing Practice (cGMP)

The current quality standards FDA enforces for the manufacture, processing, packing, and holding of drug products to ensure identity, strength, quality, and purity.