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President Biden delivered a speech yesterday highlighting the drug pricing reform measures in the Build Back Better Act — especially for insulin products — shortly after Sen. Majority Leader Chuck Schumer (D-N.Y.) released a letter outlining Democratic attempts to pass the $2 trillion bill by Christmas. Read More
The FDA’s Center for Drug Evaluation and Research (CDER) has issued two manuals for agency staff on user fees — one updated and one brand new. Read More
After a delay in 2020, the FDA has launched its new NextGen Portal for drug manufacturers to use for reporting volume data for drugs and biologics. Read More
The FDA has closed out its three-year-old warning letter to Zhejiang Huahai Pharmaceutical’s site in Linhai, Taizhou because of corrective actions the manufacturer has undertaken. Read More
Following a year in which vaccine manufacturing plant Emergent BioSolutions spent many months in the headlines for botching 75 million Johnson & Johnson (J&J) COVID-19 vaccines, the federal government and the troubled company have parted ways. Read More
Democrats are reportedly set to meet with the Senate parliamentarian today to start discussing healthcare components in the Build Back Better Act — and to gauge whether the chamber’s gatekeeper will object to any provisions included in the $1.75 trillion package. Read More
The FDA has revised its fiscal 2022 Generic Drug User Fee Act (GDUFA) II research priorities based on feedback gleaned from a June public workshop in which generic drugmakers critiqued the agency’s fiscal 2021 initiatives. Read More
Several different COVID-19 booster shot combinations appear to improve protection against infection but the messenger RNA (mRNA)-based jabs from Pfizer and Moderna might be the most effective. Read More
The FDA canceled its scheduled Oncologic Drugs Advisory Committee (ODAC) meeting last week during which it had planned to discuss two cancer drugs that hold accelerated approvals (AA). Read More