OR WAIT null SECS
May 17, 2019
The agency is reviewing Xeljanz (tofacitinib) because of the risk of blood clots in the lungs.
May 15, 2019
FDA is examining and updating its programs for overseeing global operations and international affairs.
The agency is warning these manufacturers that they are putting consumers at risk with substandard manufacturing practices.
May 10, 2019
The guidance will assist sponsors in demonstrating a proposed therapeutic protein product is interchangeable with a reference product.
May 09, 2019
The new guidance was issued to assist applicants in determining which abbreviated pathway to take for submitting marketing applications.
The new guidance document discusses reproductive toxicity testing and labeling recommendations.
May 07, 2019
The agency approved Ruzurgi (amifampridine) tablets for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in patients six to less than 17 years of age.
FDA sent a warning letter to Dong Yuan Technology Co., Ltd. detailing CGMP violations including failure to follow laboratory and process controls.
May 03, 2019
The agency is updating its warning requirements for eszopiclone, zaleplon, and zolpidem after reports of complex sleep behaviors.
The agency approved Benlysta (belimumab) intravenous infusion for treatment of children with systemic lupus erythematosus.