June 12, 2025
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 […]
June 12, 2025
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 […]
June 12, 2025
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 […]
June 12, 2025
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 […]
June 12, 2025
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 […]
June 12, 2025
A new analysis provided “strong” support for starting fecal immunochemical test (FIT) screening at ages 40-49 rather than at the currently recommended age of 50. An […]
June 12, 2025
CHICAGO — Prostate-specific antigen (PSA) levels could help guide treatment decisions for patients with metastatic hormone-sensitive prostate cancer, according to real-world findings from the IRONMAN study. […]
June 12, 2025
The Royal College of General Practitioners (RCGP) has warned that GP partnerships are under threat, as the number of partners in England has dropped by 25% […]
June 12, 2025
MINNEAPOLIS — The vaginal birth after cesarean (VBAC) calculator may overestimate the likely success rate of a VBAC following induction of labor (IOL), according to research […]
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