The Center for Drug Evaluation (CDE) has released the 65th batch of chemical generic reference preparations, adding 35 new specifications to the list and updating information on 44 previously published specifications. This batch reflects the CDE’s ongoing efforts to expand and refine the availability of generic drugs in the market.
Details of the Release
In this release, 35 new specifications were added to the list of chemical generic reference preparations. Additionally, information on 44 previously published specifications was updated to ensure accuracy and completeness. These updates are crucial for maintaining the reliability and accessibility of generic drugs for patients and healthcare providers.
Review Outcomes
Twenty – three specifications failed the review due to the uncertain status of their originators or a lack of sufficient safety and efficacy data. This rigorous review process ensures that only high – quality and safe generic drugs are approved for use, safeguarding public health and maintaining the integrity of the drug approval process.-Fineline Info & Tech
