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Electronic 510(k) Submissions Ahead (FINALLY!)

FDA Law Blog

Mullen — Last month, FDA announced two important steps towards accepting electronic 510(k) submissions. As discussed in an earlier post ( here ), CDRH piloted the eSTAR electronic submission template last year. As discussed in an earlier post ( here ), CDRH piloted the eSTAR electronic submission template last year.

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You don’t need X-Rays in a child with bronchiolitis, croup, asthma, or first time wheezing

PEMBlog

Special thanks to Todd Florin, MD, MSCE who contributed to this post – he is also an expert on respiratory and infectious emergencies. A common phenomenon in EDs around the country, this scenario is only made worse by typical spikes in patient volumes during respiratory viral seasons.

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Be The Market: How Doctors Should Invest Their Money

The Motivated MD

You spend your life dedicated to patient care while still hoping to leave work and have the energy to be mentally and physically present for your families and friends. I am not liable for any loss of profit or any other commercial damages, including but not limited to special, incidental, consequential, or other damages.

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Knowing More About Photo-Chemical Etching

CDOCS

The process involves exposing the workpiece to a special chemical solution and selectively corrode defined areas. Different techniques are used for exposing the photoresist, and these are through contact exposure, proximity exposure, projection, direct laser imaging, and electron beam.</p>

IT 52
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I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 2)

FDA Law Blog

At least two investigators must be present during the on-site inspection, but teams can include DEA special agents or task officers from state and local law enforcement and regulatory agencies. The registrant’s employees together with the investigators conduct a closing physical count of the drugs to be audited.

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I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 2)

FDA Law Blog

At least two investigators must be present during the on-site inspection, but teams can include DEA special agents or task officers from state and local law enforcement and regulatory agencies. The registrant’s employees together with the investigators conduct a closing physical count of the drugs to be audited.

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Screening for Dementia: A Podcast with Anna Chodos, Joseph Gaugler and Soo Borson

GeriPal

I heard this beautiful thing the other day, which was to an electronic medical record, I am not a whole person. What I know is required, and I think this may be a national requirement for the D SNP beneficiaries, for people in those programs, those people who are a D SNP enrollee, dual special needs plans, which are Medicare, Medicaid.

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