The FDA issued a warning letter to Chinese API maker Zhejiang Huahai, the company implicated in a global recall of contaminated valsartan, for failing to adequately investigate the root cause…

The FDA withdrew a proposed rule in December that would have allowed generic drugmakers to independently update and distribute revised labeling to reflect new safety data. Source: Drug GMP Report

The FDA cited eight drugmakers for a variety of quality and other violations observed during agency inspections. Source: Drug GMP Report

The FDA denied a petition from several pharmaceutical and outsourcing facilities urging the agency to keep implantable testosterone pellets off its Difficult to Compound list — but noted that so…

Generic drugmakers urged the FDA to allow for more flexibility in draft guidance on product identifiers under the Drug Supply Chain Security Act (DSCSA). Source: Drug GMP Report

The FDA issued warnings to five drug manufacturing facilities for numerous CGMP deficiencies and other issues. Source: Drug GMP Report

The EMA is seeking stakeholder feedback on a draft guideline on the quality of water for pharmaceutical use. Source: Drug GMP Report

The FDA is streamlining its reporting of inspections for sterile injectable drugs to help make risk-based regulatory decisions. Source: Drug GMP Report

The FDA issued 483s to five drug manufacturers, taking them to task for quality issues that included sanitation and testing practices. Source: Drug GMP Report

Sens. Orrin Hatch (R-Utah) and Michael Bennet (D-Colo.) announced a bill that would update what they say are outdated drug labeling standards. Source: Drug GMP Report