June 17, 2024
IMPACT INNOVATION PREDICTABILITY ACCESSFDA’s Center for Drug Evaluation and ResearchJanuary 2021 Director’s Message Welcome to the FDA’s Center for Drug Evaluation and Research’s (CDER’s) annual report, […]
June 17, 2024
On This Page Date: July 23, 2024 Time: 1:00 PM – 2:00 PM ET Visit CDER Small Business and Industry Assistance Page ABOUT THIS WEBINAR (Hosted […]
June 17, 2024
On average, FDA determines that the vast majority of all expanded access requests may proceed. Sometimes called “compassionate use”, expanded access is a potential pathway for […]
June 17, 2024
For Post-Marketing Reports Drugs: FDA required that applicants electronically submit all ICSRs, ICSR attachments, and periodic safety reports. Refer to FDA Adverse Events Reporting System (FAERS) […]
June 17, 2024
On this page, you will find information about: What is expanded access? Sometimes called “compassionate use”, expanded access is a potential pathway for a patient with a serious […]
June 17, 2024
TOPLINE: The artificial intelligence (AI) chatbot ChatGPT can significantly improve the readability of online cancer-related patient information while maintaining the content’s quality, a recent study found. […]
June 17, 2024
Docket Number: FDA-2022-D-1981 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance provides information to applicants on how FDA intends to assign […]
June 17, 2024
BOSTON — Patients who have had a stroke are thought to be at a higher risk for another one, but oral anticoagulation with edoxaban led to […]
June 17, 2024
BOSTON — A common stroke risk calculator can help electrophysiologists and cardiologists distinguish which patients with subclinical atrial fibrillation (SCAF) are most likely to benefit from […]