We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA has approved label changes for general anesthetic and sedation drugs given to children younger than 3 years old because of the possible risks to their brain development. Read More
The European Medicines Agency should focus on real-world evidence and big data to assess the impact of the agency’s pharmacovigilance activities on industry. Read More
The European Medicines Agency should focus on real-world evidence and big data to assess the impact of the agency’s pharmacovigilance activities on industry. Read More
The type of postmarket safety report required for a combination medical product will be based on whether the product was approved through a drug, biologic, or device application, according to the FDA’s final rule published today. Read More
As of the end of fiscal 2015, postmarket requirements were fulfilled for 69 percent of NDAs, marking a slight decline from the previous fiscal year. Read More
Sun Pharmaceuticals has initiated a recall of more than 30,000 bottles of bupropion hydrochloride extended-release tablets for the treatment of major depressive disorder and seasonal affective disorder. Read More
Of 1,583 postmarketing trials required to be performed from fiscal years 2008 to 2014, only 373 trials or 23.5 percent, were completed by the end of fiscal 2014, according to a new report from the FDA. Read More
Sun Pharmaceuticals has initiated a recall of more than 30,000 bottles of bupropion hydrochloride extended-release tablets for the treatment of major depressive disorder and seasonal affective disorder. Read More