The FDA placed valsartan manufacturer Zhejiang Huahai on an import alert and the EMA issued a noncompliance statement barring Europe’s drugmakers from using the company’s API in their blood pressure…

The European Medicines Agency entered the third phase of its plan to keep industry gears moving while the agency prepares for the UK’s exit from the EU, and said it…

Keystone Laboratories of Memphis, Tennessee, was hit with a consent decree ordering the company to stop selling over-the-counter drugs until it complies with current manufacturing practice requirements. Source: Drug GMP…

The FDA issued draft guidance that outlines what the agency considers an ideal and robust verification system that’s also in line with legislative requirements. Source: Drug GMP Report

The FDA issued warning letters to four drugmakers over various CGMP violations at their facilities, some of which created risks of product contamination. Source: Drug GMP Report

The FDA released its latest semi-annual regulatory agenda listing the agency’s planned rulemakings for pharmaceuticals, including: Source: Drug GMP Report

The FDA issued final guidance on “single-dose” and “multiple-dose” containers for injectable medical products — introducing a new term “single-patient use.” Source: Drug GMP Report

The FDA proposed a rule to allow OTC drugs sterilized by irradiation to be marketed legally without an agency-approved NDA or ANDA. Source: Drug GMP Report

The FDA issued final guidance for outsourcing facilities on compounding and repackaging radiopharmaceuticals, along with draft guidance on insanitary conditions at compounding facilities. Source: Drug GMP Report

The FDA issued Form 483s to five foreign manufacturers, citing a variety of quality concerns. Source: Drug GMP Report