FDA Panel Rejects Sintilimab Clinical Trial Data From China

The new drug for lung cancer had clinical trial data only from China; FDA officials made clear their opposition to using studies conducted in only one nation as a basis for drug approvals.
Medscape Medical News

source https://www.medscape.com/viewarticle/968320?src=rss

Comments

Post a Comment

Popular posts from this blog

New AAFP practice guideline sets blood pressure targets for adults with hypertension

From 1977 to 2003, seven Joint National Committees (JNC), sponsored by the National Heart, Lung, and Blood Institute (NHLBI), produced consensus multi-specialty guidelines on the diagnosis and management of hypertension. In 2013, well into the development of JNC8, the NHLBI abruptly turned the process over to the American College of Cardiology/American Heart Association (ACC/AHA). The JNC8 committee independently published an evidence-based guideline in JAMA that raised the blood pressure treatment threshold in most older adults from 140/90 to 150/90 mm Hg. Concerned about conflicts of interest and other deviations from Institute of Medicine-recommended practices for developing trustworthy guidelines , primary care groups, including the American Academy of Family Physicians (AAFP), declined to participate in the ACC/AHA guideline panel. And the longstanding edifice of hypertension guidelines fractured. In 2017, the ACC/AHA released its clinical practice guideline , which most notab...
Read more

A Large Multicenter Prospective Study of Community-Onset Healthcare Associated Bacteremic Urinary Tract Infections in the Era of Multidrug Resistance: Even Worse than Hospital Acquired Infections?

Healthcare-associated (HCA) infections represent a growing public health problem. The aim of this study was to compare community-onset healthcare associated (CO-HCA) bacteremic urinary tract infections (BUTI) and hospital-acquired (HA)-BUTI with special focus on multidrug resistances (MDR) and outcomes. ITUBRAS-project is a prospective multicenter cohort study of patients with HCA-BUTI. All consecutive hospitalized adult patients with CO-HCA-BUTI or HA-BUTI episode were included in the study. Exclusion criteria were: patients < 18 years old, non-hospitalized patients, bacteremia from another source or primary bacteremia, non-healthcare-related infections and infections caused by unusual pathogens of the urinary tract. The main outcome variable was 30-day all-cause mortality with day 1 as the first day of positive blood culture. Logistic regression was used to analyze factors associated with clinical cure at hospital discharge and with receiving inappropriate initial antibiotic trea...
Read more