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Prizing collaboration and reduced burdens on drugmakers, the European Medicines Agency hopes to bolster a stronger drug development process in the coming years. Read More
The FDA is recommending that drugmakers create safety assessment committees and formalized surveillance plans to watch for serious adverse events in clinical trials to decide when safety data should be unblinded. Read More
The FDA has delayed BioMarin’s plans to market drisapersen, the company’s Duchenne muscular dystrophy candidate, with a complete response letter calling for more evidence of the therapy’s benefits. Read More
With an eye toward patient-focused drug development, the FDA is seeking feedback on a compilation of diseases and outcome measures gathered together under a new pilot program. Read More
Robert Califf, President Barack Obama’s choice to head the FDA, is calling for clinical trial reform, but does not believe new regulations are needed. 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on a global scale, as the World Health Organization — with the help of international regulators — has released draft guidance that attempts to bridge gaps between the principles of good data and record management and actual practices.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
Drugmakers that have not started complying with worldwide track and trace regulations are behind the curve, as most countries only allow for two to three years for implementation, a supply chain expert cautions. Read More
The FDA again has slapped India’s Cadila Pharmaceuticals with a warning letter, this time alleging GMP violations — including a lack of quality controls, improper recordkeeping and inadequate investigations — at its Moraiya formulation plant and Ahmedabad API facility. Read More
A number of drugmakers got good news from the European Medicines Agency’s Committee for Medicinal Products for Human Use, including two companies looking to have their lung cancer drugs approved in Europe. Read More
A journal article asking the FDA to defy its own policies concerning drug reimportation and mass compounding to combat rising drug prices comes from an unusual source: the agency’s former second-in-command. Read More
With an eye toward patient-focused drug development, the FDA is seeking feedback on a compilation of clinical tools gathered together under a new pilot program. Read More