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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 last week. Read More
Nearly every state has opened investigations into whether the companies coordinated efforts to keep generic drug prices artificially — and illegally — high. Read More
Biosimilar companies are hamstrung by patent schemes, misguided legislation, rebate traps and other hurdles to market entry that have cost the U.S. healthcare system $7.6 billion since 2015, the Biosimilar Council claims in a new analysis. Read More
The FDA is scrapping the risk evaluation and mitigation strategy (REMS) for Gilead’s blockbuster HIV drug Truvada and its generics — so manufacturers will no longer have to include educational materials on the drug’s use. Read More
Teva won’t use speakers’ bureaus and won’t provide direct or indirect financial support for branded or unbranded information promoting opioids, the AG said. Read More
“These products have not been demonstrated to be safe or effective for any use and may keep some patients from seeking appropriate, FDA-approved therapies,” the agency said. Read More