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Regulators around the world are joining forces as part of an investigation into why a patient died after being treated in a Phase 1 clinical study conducted by Biotrial, a French clinical research organization. Read More
The FDA repeatedly blasted overseas drugmakers last year for disregarding compliance orders and not living up to their own promises to carry out proper cGMP practices for active pharmaceutical ingredients. Read More
Indian analysts attribute ongoing quality control issues with pharmaceutical exports to a dearth of pharmaceutical inspectors and a lack of uniform standards in the country. Read More
Roche has settled its legal feud over Tarceva with Glenmark Pharmaceuticals, with both sides agreeing to drop lawsuits over patent rights in India. 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 is asking India-based Sun Pharmaceuticals to conduct tests and turn over reams of paperwork in response to a warning letter alleging more than a dozen cGMP violations. 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