General Terms (19)
19 terms in this category. Navigate definitions and jump to related workflows.
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.
Establishment Inspection Report(EIR)
The formal written report FDA issues at the conclusion of a facility inspection documenting findings and classification.
European Medicines Agency(EMA)
The European Union agency responsible for the scientific evaluation, supervision, and safety monitoring of medicines.
FDA Form 483(Form 483)
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.
Food and Drug Administration(FDA)
The US federal agency responsible for protecting public health by regulating food, drugs, biologics, medical devices, and cosmetics.
Pharmaceuticals and Medical Devices Agency(PMDA)
Japan's regulatory agency responsible for approving pharmaceuticals, medical devices, and regenerative products.
Pre-Approval Inspection(PAI)
An FDA facility inspection conducted before approval of an NDA, BLA, ANDA, or equivalent to verify cGMP readiness and submission accuracy.
