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.
The FDA placed valsartan manufacturer Zhejiang Huahai on an import alert Friday and the EMA issued a noncompliance statement barring Europe’s drugmakers from using the company’s API in their blood pressure products. Read More
The FDA slapped Phoenix-based outsourcing facility Atlas Pharmaceuticals with a warning letter for adulterated and misbranded drug products as well as numerous CGMP violations stemming from an inspection carried out in August and September 2017. Read More