The Center for Drug Evaluation (CDE) is currently soliciting feedback on the 77th batch of chemical generic reference preparations, with a deadline set for December 20, 2023. This batch includes 26 new specifications and 57 additional specifications. However, 18 specifications did not pass the review process, primarily due to issues such as the absence of reference preparation status, discrepancies with domestically approved drugs regarding dosage ranges, and failures during re-review.- Flcube.com
CDE Requests Feedback on 77th Batch of Chemical Generic Reference Preparations by December 20
