FDA Approval

A written regulatory communication from FDA to an applicant, who submitted request to the agency to approve marketing or to license medical product, stating that the agency can approve the application or abbreviated application if specific additional information or material is submitted or specific conditions are met. An approvable letter does not constitute approval of any part of an application or abbreviated application and does not permit marketing of the drug that is the subject of the application or abbreviated application. The letter often lists minor deficiencies in the product documentation that have to be corrected, often involves labeling changes, and possibly requests sponsor commitment to do post-approval studies. (NCI Thesaurus)

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FDA Act Type Terminology

Terminology codelist used to describe the principal observations for human clinical and non-human non-clinical studies for the FDA CDA guide.

FDA

An agency in the U.S. federal government whose mission is to protect public health by making sure that food, cosmetics, and nutritional…

FCRL4 wt Allele

Human FCRL4 wild-type allele is located in the vicinity of 1q21 and is approximately 24 kb in length. This allele, which encodes…

FCRL4 Gene

This gene may be involved in B cell receptor signaling.

FCR Regimen

A chemoimmunotherapy regimen consisting of fludarabine, cyclophosphamide and rituximab used for the treatment of chronic lymphocytic leukemia.

FCHSD1 wt Allele

Human FCHSD1 wild-type allele is located in the vicinity of 5q31.3 and is approximately 12 kb in length. This allele, which encodes…