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Genentech and Pfizer urged the FDA in written comments to make its draft guidance on statistical analyses of analytical similarity data for biosimilars more specific and narrower in scope. Read More
The FDA fleshed out its public numbers on ANDA approvals for the first month of GDUFA II, notably underscoring 26 first-cycle approvals, plus two tentative. Read More
Many manufacturers are offering larger rebates on medicines, but in many cases patients do not share in the negotiated discounts, according to a new analysis from PhRMA. Read More
The European Medicines Agency’s pharmacovigilance committee revised its methods for measuring the health outcomes of its major regulatory interventions, aiming to improve industry safety monitoring practices and find out which activities have been the most successful. Read More
The European Medicines Agency and the European Commission broadened their guidance on Brexit to include new information for manufacturers of orphan drugs, generics and biosimilars, as well as hybrid medicines that rely on reference product data as well as new clinical trial findings. Read More
The FDA remains seriously concerned about drug shortages as manufacturers in Puerto Rico continue their slow recovery from Hurricane Maria, but the shortage of IV saline product should improve by the end of the year, Commissioner Scott Gottlieb said in his latest update. Read More
The FDA approved Invidior’s Sublocade, the first once-monthly buprenorphine injectable as a medication-assisted treatment for opioid use disorder. Read More