Summary Company Announcement Date: March 27, 2023 FDA Publish Date: March 28, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to Presence of […]

Docket Number: FDA-2017-D-3101 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research, Office of Pharmaceutical Quality The Food and Drug Administration (FDA or Agency) […]

On June 12, 2025, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) for adults with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) […]

GDUFA III includes several enhancements to the abbreviated new drug application (ANDA) assessment process to maximize the efficiency and utility of each assessment cycle. These enhancements […]

CDER would like to assist sponsors and applicants who have not previously submitted standardized study data and who are planning a submission to CDER. We offer […]

FDA would like to assist sponsors and applicants who have not previously submitted in eCTD v4.0. We offer a process to validate sample new eCTD v4.0 […]

This page provides information about the electronic submission of regulatory information to the Center and the review of it by CDER staff.  The Electronic Common Technical […]

On June 12, 2025, the Food and Drug Administration approved mitomycin intravesical solution (Zusduri, UroGen Pharma) for adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder […]

FDA approves taletrectinib for ROS1-positive non-small cell lung cancer On June 11, 2025, the Food and Drug Administration approved taletrectinib (Ibtrozi, Nuvation Bio Inc.), a kinase […]