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The European Commission released new guidelines clarifying the responsibilities of qualified persons overseeing global, multisite manufacturing operations and the data they need to collect. Read More
Starting next June, drugmakers must use a new centralized database to file product safety update reports, the European Medicines Agency says. Read More
Manufacturers of new biologics could receive up to eight years of exclusivity in 12 countries under the Trans Pacific Partnership, a close reading of the deal shows. The specific terms of the contentious trade pact, which President Barack Obama inked with 11 other countries in October, were publicly released Nov. 6. Read More
The head of the World Health Organization is speaking out against the Trans Pacific Partnership, contending that the 12-country deal could cause drug prices to spike. Read More
India’s Central Drugs Standard Control Organization has unveiled three new guidelines that it says paves the way forward for more clinical trials in the country by reducing red tape for clinical research. Read More
Good data integrity practices are drawing attention on a global scale, as the World Health Organization — with the help of international regulators — has released draft guidance that attempts to bridge gaps between the principles of good data and record management and actual practices. Read More
Roche’s Genentech unit and partner Exelixis scored a regulatory win Tuesday, with the FDA approving Cotellic as part of combination treatment for advanced melanoma. Read More