Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.
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
The FDA issued a warning about the risk of hepatitis B virus (HBV) becoming an active again in any patient who has a current or previous infection with HBV and is treated with certain direct-acting antiviral (DAA) medicines for the hepatitis C virus. Read More