FDA’s Intended Use Final Rule

Non-binding Guidance

Biscuits & Jam

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Encore: Jessica B. Harris Believes in a Welcome Table 42:14

10 days ago42:14

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Episode Description: Jessica B. Harris may have been born and raised in New York City, but she has Tennessee roots through her father and has spent much of her life split between homes in the Northeast and the South – specifically New Orleans. For more than fifty years, she has been a college professor, a writer, and a lecturer, and her many books have earned her a reputation as an authority on food of the African Diaspora, as well as a lifetime achievement award from the James Beard Foundation. A few years back, Netflix adapted her book, High on the Hog: A Culinary Journey from Africa to America , into a 4 part docuseries. And I’m very proud to say that she’s a longtime contributor to Southern Living with a regular column called The Welcome Table. This episode was recorded in the Southern Living Birmingham studios, and Sid and Jessica talked about her mother’s signature mac and cheese, the cast-iron skillet she’d be sure to save if ever her house were on fire, and her dear friend, the late New Orleans chef Leah Chase. For more info visit: southernliving.com/biscuitsandjam Biscuits & Jam is produced by : Sid Evans - Editor-in-Chief, Southern Living Krissy Tiglias - GM, Southern Living Lottie Leymarie - Executive Producer Michael Onufrak - Audio Engineer/Producer Jeremiah McVay - Producer Learn more about your ad choices. Visit podcastchoices.com/adchoices…

4 years ago 24:18

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This edition of Ropes & Gray’s podcast series, Non-binding Guidance, focuses on one of the most fundamental concepts in FDA regulatory law: intended use. On August 2, FDA issued a final rule amending its drug and medical device regulations describing the types of evidence the Agency considers relevant to determining a product’s “intended use.” The new regulations just took effect on September 1. Join Kellie Combs, a partner in Ropes & Gray’s life sciences regulatory and compliance practice, Doug Hallward-Driemeier, a partner in the litigation & enforcement practice and head of the firm’s appellate & Supreme Court practice, and Josh Oyster, a senior associate in the life sciences regulatory and compliance practice group, as they discuss this final rule and what its implementation means for the drug and medical device industry.

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