Between 2015 and 2016, the number of GMP inspections conducted by European Economic Area authorities of non-EU sites dropped by nearly 25 percent, but the authorities reported more findings of…
Genentech and Pfizer urged the FDA in written comments to make its draft guidance on statistical analyses of analytical similarity data for biosimilars more specific and narrower in scope. Source:…
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. Source: Drug Industry Daily
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. Source: Drug Industry…
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…
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…
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 FDA approved Invidior’s Sublocade, the first once-monthly buprenorphine injectable as a medication-assisted treatment for opioid use disorder. Source: Drug Industry Daily
The FDA issued a warning letter to a Texas drug compounding facility after it failed to resolve problems identified during an inspection, including serious deficiencies in sterile drug processing. Source:…
Dr. Reddy’s Laboratories said it will contest a class-action lawsuit by investors who claim the company made false or misleading statements about its quality system. Source: Drug Industry Daily