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In cases where the FDA must redact information from the Clinical Study Report, the agency will handle the process in-house rather than through a third party. Read More
Most litigation against opioid manufacturers has focused on accusations of fraud or misleading marketing that they claim contributed to the addiction crisis, but a new class-action suit holds them responsible for spiraling insurance costs. Read More
The legislation eliminated fees for supplements and establishments, as well as the establishment fee special rule that applied to establishments that manufacture positron emission tomography drugs. Read More
“Such a step could help restore some semblance of reality to the relationship between list and negotiated prices, and thereby boost affordability and competition,” he said. Read More
The Clinical Trials Transformation Initiative is developing several new sets of recommendations relating to clinical trials — on the qualification of investigators, the potential legal and regulatory hurdles to decentralized trials, and obstacles to incorporating mobile technology, according to its 2017 annual report. Read More
An FDA advisory committee voted Thursday that Infocare’s NDA for stannsoporfin injection’s overall risk-benefit profile does not support the drug’s approval. Read More
The administration is considering whether to revisit if drug companies’ rebates should be allowed safe harbor from anti-kickback laws in an effort to help curb rising healthcare costs, FDA Commissioner Scott Gottlieb told the Food and Drug Law Institute’s annual meeting in Washington, D.C. Read More
The sponsor found a statistically significant benefit from plazomicin over colistin for 28-day mortality in the bloodstream infection subgroup. Read More