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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
Having naloxone widely available as an approved OTC product, is “an important public health advance and a need that we’ve been working on at the FDA,” Gottlieb said. Read More
Walgreens agreed to pay nearly $270 million to settle allegations the pharmacy giant violated the False Claims Act and overbilled Medicaid for prescription drugs. Read More