Twisted Path Yields 1st Diabetes Drug Approved Since FDA Cardio Guidelines
After FDA recently issued cardiovascular safety guidelines for diabetes medicines, many large drug makers returned to the clinic to revise their plans. But VeroScience, a small and relatively obscure company, won approval for its Cycloset medication to treat type 2 diabetes on the strength of Phase IIIb trial data that actually exceed FDA's standards
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There is one message that sponsors should take to heart from an FDA advisory committee's first pass at applying new cardiovascular outcomes standards to type 2 diabetes medicines: enroll sicker patients in pivotal trials
FDA's flexibility in applying its new guidance for cardiovascular safety of diabetes drugs will be tested in coming months as it reviews a handful of pending NDAs and enters into discussions about other drugs in late stages of development
“There is no bright-line requirement that a company possess randomized, controlled clinical studies before making so-called ‘health benefit’ claims for dietary supplements,” CRN states in petition. FTC, however, says it “makes no bright-line distinctions between categories of health-related products or claims.”