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A study of drugs granted accelerated approval by the FDA between January 2012 and July 2021 found that more than half of the required confirmatory trials missed their deadlines. Read More
Problems related to written procedures occupy three spots in the FDA’s list of top 10 observations made in drug manufacturer inspections year after year: “procedures not in writing, fully followed,” “absence of written procedures” and “written procedures not established/followed.” Together, they represent 41.2 percent of all observations cited on FDA Form 483s to drugmakers in 2022. Read More
AbbVie and Johnson & Johnson (J&J) are voluntarily withdrawing accelerated approval for their blockbuster oncology drug Imbruvica (ibrutinib) for two blood cancers following disappointing confirmatory trial results. Read More
The Center for Biologics Evaluation and Research (CBER)’s ability to hire and retain staff will be a key challenge for fiscal 2024, according to Peter Marks, the center’s director, who spoke last week at an Alliance for a Stronger FDA webinar. Read More
A federal appeals court has cleared the way for PhRMA’s complaint against Minnesota’s plan to have manufacturers provide insulin for free to move forward. Read More
The FDA has withdrawn its approval of Makena, Covis Pharmaceutical’s drug to reduce the risk of pre-term birth in at-risk women, citing the lack of a favorable postmarket benefit-risk assessment and ending Covis’ hopes for an “orderly wind-down” period. Read More
Arbutus Biopharma and Genevant Sciences have filed a complaint in a federal court alleging that Pfizer and BioNTech violated five patents related to their messenger RNA (mRNA) delivery technology used in the Pfizer/BioNTech COVID-19 vaccine. Read More
The European Medicines Agency (EMA) is updating its Priority Medicines (PRIME) program to include new ways to track a product’s progress toward approval and to get more timely advice from the agency. Read More
Double-checking that a Form 483 is factually correct — and that the observations make sense — are two of the most important things a firm can do when given the document, said inspection expert David Chesney, principal of DL Chesney Consulting, in a recent WCG FDAnews webinar. Read More