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Republican leaders from the House Energy and Commerce Committee have asked the FDA to provide all documents related to the agency’s criminal investigations into the heparin contamination crisis, which stemmed from Chinese manufacturing facilities. Read More
In response to growing concerns over drug quality in India, the government is proposing to create an electronic platform to monitor its drug supply. Read More
The European Medicines Agency is seeking applications to join a multidisciplinary team to help the agency develop best practices for the anonymization of clinical reports. Read More
The EMA’s Committee for Medicinal Products for Human Use is recommending EU approval of six drugs for treating a range of conditions from rare forms of cancer to chronic heart failure. Read More
The European Medicines Agency should focus on real-world evidence and big data to assess the impact of the agency’s pharmacovigilance activities on industry. Read More
FDA warning letters to foreign drug and API manufacturing facilities have increased more than tenfold so far this year compared to the same period in 2016. Read More