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FDA Issues Unsupported Safety Warning Regarding Surgical Robots for Cancer Treatment

FDA Law

Rather, FDA seems intent on regulating RAS devices almost as if they were therapeutics responsible for long term clinical outcomes. It is well out of bounds for FDA to regulate them as if they were a determinant of long term clinical outcomes. Gone are the days of tool type indications for this type of device. 21 U.S.C. §

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Hearing Loss in Geriatrics and Palliative Care: A Podcast with Nick Reed and Meg Wallhagen

GeriPal

Was there any mention about the impact that hearing loss has in communication or what we should do about it in clinical practice? Association of Sensory and Cognitive Impairment With Healthcare Utilization and Cost in Older Adults. And he is also a clinical audiologist, which is going to be key for this podcast. Transcript.

IT 102
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The FDA PDUFA VII Goals Letter (FY 2023-2027): A Review of Our Top 10 Commitments

FDA Law

Torrente, explained in a previous post , in-person meetings create important opportunities for building rapport, and lead to more robust dialogue and collegial relationships between the Agency and sponsors. based upon the anticipated clinical benefit of earlier patient access to the product.”. Livornese and Josephine M.