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The World Health Organization (WHO) has released updated guidance for quality management system (QMS) requirements for national inspectorates aimed at aligning its content to international standards, the latest QMS principles and to expanding its scope. Read More
CDER released final guidance on submitting next generation nucleotide sequence (NGS) data to support resistance assessments for antiviral drugs. Read More
CDER’s associate director for data analysis, Karthik Iyer, urged drugmakers to sign up for the agency’s quality metrics feedback program and the quality metrics site visit program, in a presentation at the Drug Information Association’s annual meeting in San Diego. Read More
Canada’s leading drug industry lobby group claims the government’s latest initiative to lower prescription drug costs will weaken innovation and investment in new drugs. Read More
Humana is taking Mallinckrodt to court over an alleged price hiking scheme for its H.P. Acthar Gel (corticotropin) that the health insurance company says forced it to overpay by $700 million over more than eight years. Read More
A federal district court in New Jersey dealt a blow on Friday to Novartis division Sandoz’s efforts to invalidate two patents for Amgen’s inflammatory disorder treatment Enbrel (etanercept). Read More
If the drug is meant to slow or arrest disease progression but not reverse it, the trial should last long enough to observe disease progression in the control group, the agency says. Read More
Health Canada released new guidelines on Friday to help prescription drug companies comply with the agency’s plain language labeling requirements. Read More