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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
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) released new contingency plans for a scenario in which the UK leaves the European Union on March 29 without a deal. Read More
The FDA released two draft guidances on Thursday outlining the agency’s latest thinking on assessments of risk evaluation and mitigation strategy (REMS) programs. Read More
The agency suggested using data from alternative sources, such as trials that use the drug for other indications or studies of similar treatments. Read More
The FDA should require a Risk Evaluation and Mitigation Strategy to ensure patient use mimics clinical trial conditions, a CDC official said. Read More