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Drugmakers developing treatments for uncomplicated vulvovaginal candidiasis should conduct two adequate and well-controlled clinical trials with a superiority design to demonstrate efficacy, the FDA says. Read More
The FDA is pushing for more uniform quality assessments in the clinical development of chewable tablets after finding significant variation among manufacturers. Read More
When given the opportunity to use real-world data for drug approvals, sponsors scramble to conceive innovative approaches, an EMA official said. Read More
A new study of oncology approvals shows a majority of the candidates approved under accelerated review with surrogate endpoints lacked validation. Read More
Drugmakers submitting ANDAs for products using transdermal delivery systems are expected to demonstrate that they made “reasonable efforts” to optimize the adhesive characteristics of their patches, the FDA says. Read More
As pharmacy benefit managers’ exclusion lists grow longer, drug developers hoping to avoid exclusion must scramble to demonstrate the clinical superiority and cost-effectiveness of their products, according to a new report. Read More
Clinical research organizations foresee specific technologies redefining trial design, but also posing data integrity risks due to minimal FDA guidance. Read More
The FDA wants clinical researchers to improve their electronic data capture systems to ensure interoperability with electronic health records used by healthcare organizations. Read More