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Australia’s Therapeutic Goods Administration is proposing expedited drug application reviews that would mirror programs in North America and Europe. Read More
The European Directorate for the Quality of Medicines and a number of foreign pharmaceutical authorities have agreed to improve information-sharing efforts and to strengthen collaboration. Read More
Prospects look somewhat grim for the life sciences industry in the UK, regardless of whether the country decides to completely divorce itself from the EU or do a “soft exit,” a think tank says. Read More
Teva Pharmaceuticals is reserving roughly $520 million to settle bribery allegations across three countries, according to the company’s latest earnings report. Read More
The EMA is revising nearly decade-old guidelines on first-in-human trials after a patient died in a French study earlier this year to offer drugmakers guidance on risk management. Read More
Industry is asking the FDA to impose stricter requirements for outsourcing facilities to qualify for an exemption that allows them to produce near replicas of approved products and compete with branded and generic drugs. Read More