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Abaco Partners, operating as Surefil, has received a seven-observation Form 483 from the FDA after a November 2021 inspection of the company’s Grand Rapids, Mich., manufacturing facility turned up observations of testing and other quality lapses. Read More
The FDA announced Friday that it’s working on a project to identify and prioritize pharmaceutical quality (PQ) and chemistry and manufacturing and controls (CMC) information that would benefit from a structured submission approach. Read More
The World Health Organization (WHO) has issued a “strong recommendation” for Pfizer’s oral antiviral Paxlovid for mild and moderate COVID-19 in people at highest risk of hospitalization, such as unvaccinated, older or immunosuppressed patients. Read More
The FDA’s latest annual report on the postmarket performance of drug and biologics firms, which covers the fiscal year Oct. 2, 2019, to Sept. 30, 2020, says 75 percent of the 816 unique postmarket requirements (PMRs) and postmarket commitments (PMCs) in the FDA’s system were on schedule. But the agency said many of the studies failed to file timely reports. Read More
The FDA’s Oncologic Drugs Advisory Committee voted nearly unanimously (16 for and one abstaining) to require makers of phosphatidylinositol 3-kinase (PI3K) inhibitors in blood cancers to complete randomized phase 3 trials with active comparators before they submit applications for approval. Read More
The FDA’s Center for Drug Evaluation and Research (CDER) released a final guidance yesterday on drugs and biologics that contain nanomaterials, noting that the agency has not yet established regulatory definitions of nanomaterials and nanotechnology. Read More
U.S. spending on drugs shot up by 12 percent in 2021 — climbing to $407 billion — due to increased use of COVID-19 vaccines and therapeutics, says a new analysis from healthcare analytics firm IQVIA. Read More
More than 25 percent of the adverse event reports in 2021 discussed by the agency’s Pharmacovigilance Risk Assessment Committee were related to COVID-19 vaccines, the agency said. Read More