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Active pharmaceutical ingredient (API) manufacturers operating in Canada must establish clearly defined and controlled manufacturing processes to ensure consistency under Health Canada’s newly finalized good manufacturing practices (GMP) guidelines. Read More
The FDA and Indian Ministry of Health & Family Welfare will begin sharing information from quality inspections of drugmakers’ manufacturing facilities. Read More
Indian officials are contemplating stripping a number of drugs of their exclusivity periods, clearing the way for companies to produce knock-off products that will bring down costs. Read More
Sponsors of new drugs seeking marketing authorization in the EU must now apply to receive a numerical code unique to the application, the European Medicines Agency (EMA) said Tuesday. Read More
The FDA has upgraded the status of Hospira’s troubled Rocky Mount, N.C., manufacturing plant to allow it to begin using the facility to manufacture new products. Read More
Three prominent Republican senators have added their voices to the growing number of critics attacking the FDA’s decision last year to approve Zogenix’s high-dose opioid Zohydro ER. Read More
The U.S. Department of Justice wants to rid the pharmaceutical industry of pay-for-performance sales compensation packages, believing they fuel fraud, off-label marketing and other deceptive behaviors, a former top prosecutor says. Read More
The European Medicines Agency is following in step with U.S. regulators and, at the request of Sweden’s medicines authority, is reviewing the efficacy of emergency contraceptives in heavier women. Read More