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Is my Software a Medical Device? Use the Digital Health Policy Navigator

FDA Law Blog

If you are a manufacturer of implants that go into the human body for the treatment of disease, it’s an easy yes that you are a manufacturer of a medical device. Please check out FDA’s presentation on this very topic – Is My Product a Medical Device?

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The Most Engaging Decision You’ll Read All Year – Five Stars

FDA Law Blog

FDA , Petitioners, a liquid nicotine manufacturer, sued FDA arguing that the Agency was arbitrary and capricious in rejecting the Petitioner’s Premarket Tobacco Application (“PMTA”) in violation of the Administrative Procedure Act (“APA”). FDA also directed manufacturers to produce detailed marketing plans.

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It’s a Bird, It’s a Plane, It’s Operation Stork Speed

FDA Law Blog

This initiative seeks to address the ongoing challenges families face in ensuring they have access to safe, reliable, and nutritious infant formula and is described by HHS Secretary Kennedy as critical to the pursuit of Make America Healthy Again. Specific timelines were not provided.

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Case Study: Six single-unit anterior crowns featuring KATANA™ multilayered Zirconia material

CDOCS

jpg]</span><br /> <em style="font-family: ubuntu;"><span style="font-size: 11px;">Figure 1: Pre-op photo of teeth #s 6-11.</span></em></p> A shape was chosen that provided more incisal embrasures to avoid getting the flat, worn-down look of the incisal edges (Figure 5).</span></p>

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PhRMA Code Revised in Response to OIG Special Fraud Alert on Speaker Programs

FDA Law Blog

Kirschenbaum — On August 6, 2021, the Pharmaceutical Research and Manufacturers of America (PhRMA) announced the release of a revised PhRMA Code on Interactions with Health Care Professionals , which takes effect on January 1, 2022. not friends, significant others, or family members of a speaker or invitee). By McKenzie E.

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Interdisciplinary Case Report

CDOCS

We need to recognize how clinical dentistry has become intertwined with digital technologies to synergistically assist us in providing enhanced diagnosis with safe and predictable treatment outcomes. & He presented with a high smile line and desired fixed natural appearing teeth.

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The Chairside Zirconia Revolution: The Evolution of Choice

CDOCS

& But, I don&rsquo;t know if anything has done as much for bringing CAD/CAM into general dentistry offices more than the ability to manufacture zirconia restorations chairside.</span></p> .& I would wager that anyone that has used the Primescan would never give it back for their Omnicam or Bluecam.&

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