Limitation Of Use Based On Conditional Approval
Cancer Terms ->
NCI Administrative Concepts ->
Medical Product Usage And Evaluation ->
Limitation Of Use -> Limitation Of Use Based On Conditional Approval
Limitation Of Use Based On Conditional Approval Definition
The limitation use of the drug (exclusion of use) when approval is based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity [21 CFR 314.510], or a product may be approved with restricted distribution to assure safe use [21 CFR 314.520]. The term conditional approval is used when product was approved under Subpart H (drug) or Subpart E (biologic).
Limitation Of Use Based On Conditional Approval Synonyms
Limitation of Use Based on Conditional Approval, Conditional Approval
Terms in Limitation Of Use Based On Conditional Approval category
Copyright © Cancer Terms 2014 All rights reserved. | Terms of Use | Low Carb Foods
No reproduction or republication permitted.