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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In a revised draft guidance released yesterday, the FDA outlined its latest thinking on prescription drug supply-chain verification systems that companies will need to implement to comply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
The changes the agency is considering would involve less standardization of “quality metrics and definitions” and allow facilities more leeway. Read More
The International Coalition of Medicines Regulatory Authorities (ICMRA) is about to start two pilot projects on drug manufacturing inspections, a senior industry official said. Read More
Teva Pharmaceuticals and Natco Pharma have announced the launch of the first generic versions of Revlimid (lenalidomide) in the U.S., a move that will take a bite out of Bristol Myers Squibb’s (BMS) profit from the blockbuster blood cancer drug. Read More