The Center for Drug Evaluation (CDE) has released the 66th batch of chemical generic reference preparations, adding 27 new specifications and updating information for 33 previously published specifications. The document is open for public feedback until January 20, 2023.
Details of the Release
The latest batch includes 27 new specifications, expanding the range of available chemical generic reference preparations. Additionally, 33 previously published specifications have been updated to reflect the latest information. The CDE is seeking public feedback on these changes, ensuring transparency and stakeholder engagement in the regulatory process.
Review Outcomes
Seventeen specifications failed the review due to the uncertain status of their originators or a lack of compound evidence. This highlights the CDE’s commitment to maintaining high standards for reference preparations, ensuring that only well-documented and reliable products are included in the list.
Future Outlook
The release of the 66th batch of chemical generic reference preparations underscores the CDE’s ongoing efforts to enhance the availability and quality of generic drugs. By adding new specifications and updating existing ones, the CDE aims to support the development and approval of generic medications, ultimately benefiting patients through increased access to affordable treatments.-Fineline Info & Tech
