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The FDA announced on Tuesday that it will begin removing out-of-date drug listing records from its database in one month and urged companies to update any inaccurate listings as soon as possible. Read More
The amended regulation requires patentholders to report the actual price they charge — including direct or indirect third-party discounts or rebates. Read More
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