Remove Individual Remove Information Remove Manufacturing Remove Physicals
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Urinary Incontinence Revisited: George Kuchel & Alison Huang

GeriPal

It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit. Incontinence and avoiding issues can present in an older individual, in some cases, just like they do a younger person. That can be incredibly informative. Everybody ages.

IT 120
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I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 2)

FDA Law Blog

The investigators ask the registrant’s designated responsible employee, such as the Operations or Compliance Manager, for informed consent by signing a Notice of Inspection (“DEA Form-82”). Registrants should consult with counsel and their Human Resources departments in deciding whether to provide this information.

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

FDA Law Blog

The investigators ask the registrant’s designated responsible employee, such as the Operations or Compliance Manager, for informed consent by signing a Notice of Inspection (“DEA Form-82”). Registrants should consult with counsel and their Human Resources departments in deciding whether to provide this information.

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

GeriPal

We talk with Nick and Meg about: Why hearing loss is important not just in geriatrics but also for those caring for seriously ill individuals. Communication techniques we can use when talking to individuals with hearing loss. And one of the parts of that was actually doing physicals for the students and putting them in job placements.

IT 102
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Less than Meets the Eye: LDT Small Entity Compliance Guide Adds Little Insight

FDA Law Blog

Laboratories struggling to understand the myriad implications of being regulated as device “manufacturers” were hopeful that additional guidance would shed light on how to apply FDA’s existing medical device regulatory framework to their operations.

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Skinny-Label Lives to See Another Day

FDA Law Blog

There, as we explained back in July , Novartis argued that FDA’s approval of a generic ENTRESTO with indication information modified rather than simply omitted “represents a sharp departure from FDA’s statutory and regulatory mandate to require that a generic drug be the ‘same’ as its reference listed drug.”

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Psilocybin in Serious Illness: James Downar, Ali John Zarrabi and Margaret Ross

GeriPal

Alex 06:03 Is psilocybin that’s used for medicinal purposes in your studies, for example, is that manufactured or is it derived directly from mushrooms? This hypothesis Played itself out in an interesting way, Ali John 11:15 Thinking about total pain and addressing physical, emotional, social, and spiritual issues.

Illness 107