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The FDA offers expanded advice for sponsors on risk-based monitoring of clinical trials in a new final guidance that updates the agency’s previous guidance on the topic issued in 2013. Read More
While Congress may have ended the “national emergency related to the COVID-19 pandemic” with a joint resolution President Biden signed into law on Monday, the public health emergency (PHE) declared by HHS Secretary Xavier Becerra will remain in effect another month. Read More
Right now, the dual orexin receptor antagonist class of chronic insomnia medications is a scheduled class under the Controlled Substances Act. Read More
As two dueling lawsuits over the FDA-approved medical abortion drug mifepristone appear headed to the U.S. Supreme Court, hundreds of drugmakers say Friday’s ruling in the Texas case is an overstep that could weaken the federal agency and hamper future drug development. Read More
In an effort to increase industry dialogue around best practices for benefit-risk assessments, AstraZeneca (AZ) has publicly shared the structured benefit-risk (sBR) assessment framework it employs across its drug development process. Read More
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