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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
Takeda Pharmaceuticals is selling off some of its drugs in Japan in exchange for stock in a new venture to be helmed by Teva Pharmaceutical Industries. Read More
During a one-year period, the UK’s Medicines & Healthcare products Regulatory Agency conducted 47 inspections of pharma companies, during which they uncovered 27 critical findings, 169 major and 155 minor findings, according to a report. Read More
A House of Representatives committee is asking for a review of the FDA’s progress in ensuring the security of foreign facilities’ supply chains and toughening the agency’s approach to inspections at those facilities. Read More