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The European Commission formally adopted updated regulations on good manufacturing practices for pharmaceuticals generally and for investigational drugs and clinical trials more specifically. Read More
In a significant policy shift, China plans to accept data from foreign clinical trials in its drug approval process if the drug is already approved overseas. Read More
The European Medicines Agency added answers to 60 new questions in its list of inquiries from stakeholders regarding the launch of its new EudraVigilance drug safety reporting program. Read More
A major manufacturer of generic drugs in India failed to follow up as required on laboratory tests that showed its products at two facilities did not meet specifications, in some cases improperly dismissing the red-flag results, the FDA said in a warning letter. Read More
The FDA issued a warning letter to Chinese drugmaker Guangdong Zhanjiang Jimin Pharmaceutical following a May inspection of its Guangdong Province facility. Read More
A worker at an Idaho compounding pharmacy used “a worn plastic store club card” to scoop a powdered drug into empty gelatin capsules, in violation of federal regulations, the FDA said in a warning letter. Read More