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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In a revised draft guidance released yesterday, the FDA outlined its latest thinking on prescription drug supply-chain verification systems that companies will need to implement to comply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
Various supply-chain resilience measures are needed to ensure U.S. drug production before the next pandemic or other natural disaster, a National Academy of Sciences, Engineering and Medicine (NASEM) expert panel advised in a new report. Read More
Nearly $80 million will be invested to bolster commercial-scale manufacturing for companies producing innovate technologies, such as cell and gene therapies. Read More
Almost a year after admitting it manipulated safety data for its anemia drug roxadustat, Fibrogen has disclosed that the Securities and Exchange Commission (SEC) is investigating its actions. Read More