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Three Democratic representatives from the House Committee on Oversight and Reform sent a letter to the Treasury Department and the Department of Justice (DOJ) Monday, expressing their alarm at certain companies claiming tax benefits from their opioid settlement expenses. Read More
Despite the fact that many states have lifted their mask mandates and the last surge of a COVID-19 variant of concern peaked several weeks ago, we are nowhere near public health officials announcing the end of the public health emergency, according to epidemiologists who track COVID-19. Read More
“The evidence shows antibiotics are not needed by most children and young people with middle ear infections,” said Paul Chrisp, director of NICE’s Center for Guidelines. Read More
Grassley introduced proposed legislation last year that would require the FTC to report to Congress on possibly anticompetitive prescription drug-pricing practices. Read More
On Thursday night, the Senate voted 68 to 31 to pass the long-awaited $1.5 trillion, 2,700-page omnibus package to fund the federal government for fiscal year 2022 — five months after FY22 started. Read More
Whether a company is primarily a drug manufacturer or a device manufacturer, if it starts making combination products, it will have new additions to its quality management system (QMS) and will “need to learn to speak the language for both sides of the combination product,” according to a former FDA official. Read More
U.S. Bankruptcy Judge Robert Drain for the Southern District of New York has approved a revised $6 billion opioid settlement negotiated between the Sackler family, owners of OxyContin maker Purdue Pharma, and several states that appealed a previously approved proposal. Read More
Lawmakers voted last night to fund the federal government with a $1.5 trillion, 2,700-page omnibus package that includes emergency aid for Ukraine and funds the government for the rest of fiscal 2022. Read More
In a revised draft guidance released yesterday, the FDA outlined its latest thinking on prescription drug supply-chain verification systems that companies will need to implement to comply with the Drug Supply Chain Security Act (DSCSA), which goes into effect in November 2023. Read More