Term
|
Definition
|
|
Term
|
Definition
| Absorption, Distribution, Metabolism and Exceretion |
|
|
Term
|
Definition
|
|
Term
|
Definition
|
|
Term
|
Definition
| Adverse Event Reporting System |
|
|
Term
|
Definition
| Abbreviated New Drug Application (generics) |
|
|
Term
|
Definition
| Active Pharmaceutical Ingredient |
|
|
Term
|
Definition
| Bulk Approval Post Approval Changes |
|
|
Term
|
Definition
|
|
Term
|
Definition
| Biologics License Application |
|
|
Term
|
Definition
| Corrective And Preventive Action |
|
|
Term
|
Definition
|
|
Term
|
Definition
| Changes being effected within 30 days. |
|
|
Term
|
Definition
| Center for Biologics Evaluation and Research - a center within the FDA that works to ensure the safety and effectiveness of of biological products |
|
|
Term
|
Definition
| Center for Drug Evaluation and Research - a center within FDA, that oversees the effectivenss of drug products |
|
|
Term
|
Definition
| Centers for Disease Control and Prevention |
|
|
Term
|
Definition
| Center for Devices and Radiological Health |
|
|
Term
|
Definition
|
|
Term
|
Definition
| Certificate to Foreign Governments - required by certain nations to prove that an exported product is being manufactured to the requirements of GMPs provided by for export of legally marketed devices. |
|
|
Term
|
Definition
| Code of Federal Regulations |
|
|
Term
|
Definition
| Center for Food Safety and Applied Nutrition -a center within the FDA that makes sure all and cosmetics are safe for the consumer. |
|
|
Term
|
Definition
| Current Good Manufacturing Practices |
|
|
Term
|
Definition
| Clinical Hold - FDA order to delay proposed clinical trials or to suspend an ongoing investigation |
|
|
Term
|
Definition
|
|
Term
|
Definition
| Clinical Investigator Brochure |
|
|
