The Center for Drug Evaluation (CDE) has released the 58th and 59th batches of chemical generic reference preparations, adding 15 and 59 new specifications respectively. The public feedback deadlines for these batches are May 10 and June 30, 2022.
Updates and Feedback
The 58th and 59th batches saw 28 and 32 specifications updated respectively. Among the drugs that failed the review, most were deemed unqualified due to issues such as illegibility as generic reference preparations or other reasons.-Fineline Info & Tech
