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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. 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

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. Registrants should consult with counsel and their Human Resources departments in deciding whether to provide this information.

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Through Enforcement Discretion, FDA Facilitates Market Entry for New Infant Formulas (For Now); President Invokes Defense Production Act

FDA Law Blog

If FDA concludes otherwise, proceeding to market with the formula could leave the manufacturer vulnerable to regulatory action. The guidance offers an opportunity that could be of special interest to foreign manufacturers who already market infant formula in other countries and have considered entering the U.S.

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

GeriPal

So in our trial, because of security reasons, we are required by Health Canada to store the substance in a special secure area in my office. 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? James 01:34 Yeah, right on.

Illness 107
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Aging and Climate Change: Karl Pillemer, Leslie Wharton, & Ruth McDermott-Levy

GeriPal

I actually wonder though, since we’re on a GeriPal broadcast, I think that people are under emphasizing the special risk of older people. So it is an enormous mental, physical health benefit because we feel we’re still part of the world and we’re making a difference, and we are learning and we’re engaged.