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- Industry groups urge FDA to add clarity and flexibility to manufacturer-payor communication guidanceIndustry associations and other stakeholders have asked the U.S. Food and Drug Administration to give more detail and flexibility in its updated guidance on how drug and device makers talk with pay…
- Capricor to submit additional data to FDA after negative advisory committee vote on Duchenne therapyCapricor Therapeutics announced it will request the FDA to review new data and analyses for its experimental treatment for Duchenne muscular dystrophy. The move follows a recent negative vote from…