Remove Manufacturing Remove Physicals Remove Provider Remove Specialization
article thumbnail

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

FDA Law Blog

We are providing a post in three parts on cyclic and on-site inspections in which we focus on the background of inspections, how investigators conduct them, and how registrants should proactively prepare for and manage them. The policies and procedures should include a section on how the registrant handles DEA inspections.

article thumbnail

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

FDA Law Blog

We are providing a post in three parts on cyclic and on-site inspections in which we focus on the background of inspections, how investigators conduct them, and how registrants should proactively prepare for and manage them. The policies and procedures should include a section on how the registrant handles DEA inspections.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

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.

article thumbnail

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 109
article thumbnail

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. What do we do to very concretely provide heat shelters and cool shelters? The Inflation Reduction Act provides enormous tax benefits to people who get heat pumps or put solar on their roofs.