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) […]
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 […]
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. […]
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 […]
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 […]
PARIS — A percutaneous intervention strategy based on optical coherence tomography (OCT) provides greater procedural success than an angiography-based strategy for stent optimization in calcified lesions, […]
BOSTON — A Mediterranean diet with extra virgin olive oil (EVOO) significantly reduced the risk for tachyarrhythmia recurrence after atrial fibrillation (AF) ablation in patients with […]
LISBON, Portugal — Few people with suspected heart failure and elevated N-terminal prohormone of brain natriuretic peptide (NT-proBNP) levels are receiving a diagnosis after a year, […]
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