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FDA Commissioner Scott Gottlieb on Monday outlined the agency’s plans for promoting the use of real world evidence in clinical trials in 2019. Read More
The FDA has denied a citizen petition from Pfizer calling on the agency to use the company’s method for assessing sameness in generics for its estrogen drug Premarin (conjugated estrogens). Read More
UnitedHealthcare claims the companies conspired via telephone, text messages and emails as well as one-on-one meetings at trade association gatherings. Read More
The UK government released three pieces of draft legislation that cover the regulation of drugs, devices and clinical trials in a no-deal Brexit scenario. Read More
A federal court in New Jersey issued a restraining order on Friday temporarily blocking the release of a generic version of Indivior’s opioid dependence drug Suboxone (buprenorphine and naloxone) sublingual film. Read More
Massachusetts Governor Charlie Baker last week unveiled a drug pricing plan that he claimed will save the state’s Medicaid program $80 million. Read More
The FDA announced on Friday that the impurities found in valsartan-containing blood pressure drugs may have been caused by specific chemicals and reaction conditions in the manufacturing process of the drug’s API. Read More
FDA Commissioner Scott Gottlieb welcomed the end of the 35-day partial government shutdown on Friday and said that the agency would be quickly back up and running. Read More