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The FDA issued draft guidance that outlines what the agency considers an ideal and robust verification system that’s also in line with legislative requirements. Read More
The FDA issued warning letters to four drugmakers over various CGMP violations at their facilities, some of which created risks of product contamination. Read More
The FDA issued final guidance on “single-dose” and “multiple-dose” containers for injectable medical products — introducing a new term “single-patient use.” Read More
Drugmakers need to rethink the role of their quality departments, particularly when engaging with stakeholders and the broader company, says Marla Phillips, director of health initiatives at Xavier University, who previously served as head of quality at Merck’s North Carolina facility. Read More
The FDA issued final guidance for outsourcing facilities on compounding and repackaging radiopharmaceuticals, along with draft guidance on insanitary conditions at compounding facilities. Read More
The FDA released a trio of guidances on Drug Supply Chain and Security Act (DSCSA) requirements for drugmakers to attach identifiers to their prescription drugs. Read More
The EMA expanded its investigation of valsartan impurities after a new contaminant was discovered in an Indian manufacturer’s active substance, losartan. Read More
FDA guidance on submitting field alert reports contradicts federal regulations on the time frame for when reports must be submitted, Perrigo and GlaxoSmithKline said in public comments. Read More