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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
Celldex Therapeutics has pulled the plug on a Phase 3 trial of immunotherapy Rintega in patients with EGFRvIII-positive glioblastoma after a mid-trial analysis showed the candidate fared worse than a control group. Read More
The UK’s Medicines and Healthcare products Regulatory Agency GCP Inspectorate conducted 125 GCP inspections between April 1, 2013, and March 31, 2014, yielding only two critical findings and 56 major findings among 22 commercial sponsors, according to the agency’s GCP Inspections Metrics Report. Read More
With only 2 percent to 7 percent of adult cancer patients participating in clinical trials, social media may provide a boost to enrollment with targeted messages to connect patients, caregivers and families with potential trial enrollment websites, according to a study in JAMA Oncology. Read More