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Sponsors seeking Canadian approval of new drugs or indications based on published literature or postmarketing data need to be able to prove that their drug is comparable to its reference product, regulators says. Read More
The European Medicines Agency is tightening its rules around conflicts of interest, barring individuals who take jobs in industry from serving on any of its advisory committees. Read More
A federal appeals court has granted a temporary injunction barring Sandoz from marketing its biosimilar of Amgen’s blockbuster chemotherapy drug Neupogen. Read More
The FDA increased its preapproval inspections of generics makers by 60 percent between fiscal years 2011 and 2013, but failed to conduct all of those requested by agency reviewers, a new report finds. Read More
The FDA has withdrawn at least 10 draft guidances for drugmakers published before the end of 2013 because they had become outdated or were superseded by higher agency priorities. Read More
After nearly four years of litigation, DaVita Healthcare Partners agreed Monday to pay up to $495 million to resolve a whistleblower lawsuit accusing the kidney dialysis provider of wasting drugs in exchange for sizable Medicare and Medicaid reimbursements. Read More