by inpharmedia | Jul 24, 2023 | Blog
Every product should have a sufficient level of quality to ensure its efficacy and safety. The impurities/degradation products are the ones that arise during different stages of synthesis, manufacture and storage. They should be controlled at certain level to maintain... by inpharmedia | Jan 9, 2021 | Blog
An RTR decision indicates that FDA determined that an ANDA is not substantially complete. A substantially complete ANDA is “an ANDA that on its face is sufficiently complete to permit a substantive review“. It identifies certain deficiencies and certain recurrent...
