The FDA Tuesday added immediate-release opioids to its risk evaluation and mitigation strategy (REMS) for opioid analgesics, saying the move will encourage “rational prescribing.” Source: Drug Industry Daily
The Senate Monday — by a 99 to 1 margin — passed a bipartisan legislative package targeting the opioid crisis. The move comes on the heels of House passage of…
The European Medicines Agency (EMA) is considering revisions to its guidance for sponsors of medicines for neonates and is seeking input from stakeholders by Dec. 16. Source: Drug Industry Daily
The FDA slapped Xellia Pharmaceuticals with a Form 483 after finding quality and sterility shortcomings during a May inspection of its Copenhagen facility. Source: Drug Industry Daily
Dozens of patient groups penned a letter to CVS Health’s President and CEO Larry Merlo urging the company to scrap its recently announced plan to deny coverage of drugs that…
Generic drugmakers are suing New York state over its law imposing surcharges on distributors and manufacturers of opioids, arguing the tax disproportionately hurts generic manufacturers. Source: Drug Industry Daily
The FDA flagged UBI Pharma for a slew of violations at its Hsinchu County, Taiwan, facility including inadequate environmental monitoring and sterility practices. Source: Drug Industry Daily
Sen. Claire McCaskill (D-Mo.) called on Nostrum Pharmaceuticals, a drugmaker with facilities in Kansas City, to explain a reported 400 percent price hike in its bladder infection treatment, nitrofurantoin. Source:…
The FDA Friday issued a comment request on obtaining information for evaluating bulk drug substances for use in drug compounding. Source: Drug Industry Daily
FDA Commissioner Scott Gottlieb Friday announced a four-pronged agency initiative to take on antimicrobial resistance, in part by creating incentives for drugs that treat it. Source: Drug Industry Daily