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Regulations on off-label use are not harmonized across the European Union — only 10 out of 21 surveyed member states have specific policies, according to a European Commission report. Read More
The Association of the British Pharmaceutical Industry found four drugmakers — Celgene, Takeda, Vifor Pharma and Pierre Fabre — violated the group’s code of practice by engaging in activities ranging from inadequate quality management to deceptive drug promotion. Read More
Despite the Senate defeat of a measure allowing drug importation earlier this year, House and Senate Democrats are trying again: they’ve introduced new legislation that would allow imports of prescription drugs from Canada. Read More
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