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Batches of hastily assembled drug products distributed too soon and failure to document quality systems activities were among a host of GMP issues drugmakers violated, sometimes more than a year after the FDA first expressed concerns about companies’ repeated lapses during inspections. Read More
Beginning April 1, innovative drugmakers participating in the Medicaid rebate program can expect to see their returns shrink 8 percent, under a final rule from the Centers for Medicare & Medicaid Services. Read More
Calling for an immediate reform to the FDA’s opioid approval processes, Sen. Edward Markey (D-Mass.) announced he has placed a hold on the nomination of Robert Califf as the next commissioner of the agency. Read More
Shire is taking a second shot at the FDA for its eye treatment lifitegrast, resubmitting an NDA months after the agency said it needed more information before it could approve the candidate. Read More
Tuesday’s House Oversight and Government Reform Committee hearing on drug pricing has been pushed back to Feb. 4 after a weekend blizzard buried the Washington, D.C. region in snow. Read More