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A December FDA warning letter to China’s Zhejiang Hisun Pharmaceutical outlines the company’s “systemic data manipulation” and cGMP deficiencies uncovered during a March 2015 inspection. Read More
The FDA has issued warning letters to two U.S. dietary supplement makers and a Hong Kong drugmaker — already under import alert in the U.S. — for significant cGMP violations over adulterated products and data integrity issues. Read More
The FDA has updated its list of scheduled guidances for the calendar year 2016, with a major focus on pharmaceutical quality, data integrity and generics. There are 102 planned guidances this year, compared with 92 last year. Read More
Drugmakers have asked the FDA to think “globally” with the international community as they weighed in on the agency’s draft guidance on established conditions for reporting chemical, manufacturing and control changes. Read More
A federal judge has signed off on a Justice Department-backed consent decree for a permanent injunction against Texas compounder Downing Labs. Read More
The FDA said its Center for Drug Evaluation and Research and the Office of Prescription Drug Promotion issued 47 warning letters last year, compared with 52 in 2014. Read More
The European Medicines Agency is asking for feedback on a revised guideline for the treatment of Alzheimer’s disease and other types of dementia. Read More