Regulatory Intelligence Terms (19)

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

FDA's program that inspects clinical investigators, sponsors, IRBs, and nonclinical laboratories to verify compliance with applicable regulations.

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

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

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

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

The formal written report FDA issues at the conclusion of a facility inspection documenting findings and classification.

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

A list of inspectional observations issued by FDA investigators at the end of a facility inspection when conditions may violate the FDCA or related acts.

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

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

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

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

The United Kingdom's regulatory agency for medicines, medical devices, and blood components.

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

An FDA facility inspection conducted before approval of an NDA, BLA, ANDA, or equivalent to verify cGMP readiness and submission accuracy.

Switzerland's regulatory authority for therapeutic products including medicines and medical devices.

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

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