FDA Law Blog

JUNE 28, 2021

On June 26, 2021, during the Minnesota legislature’s special session, the Minnesota House of Representatives passed HF33, an omnibus health and human services bill. If enacted, Article 5, Section 6 of HF33 would provide for a reduction to the State’s opiate product registration fee. 151.066, Subd.

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Hospital Manufacturing Specialization Medical 52

The Clinical Problem Solvers

DECEMBER 16, 2020

Moreover, center patients not only in discussions about individual decision-making but in constructing and drawing meaning from the research. Tsai has seen race-based medicine play out in clinical practice 10:45 What role should race play in making clinical decisions?

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FDA Law Blog

MAY 8, 2023

See 21 CFR 807.81(a)(3) a)(3) and 21 CFR 814.39(a) a) , and related guidance documents (e.g., here for a 510(k) device and here for a PMA device). The draft guidance follows the December 2022 enactment of the Food and Drug Omnibus Reform Act of 2022 (FDORA).

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GeriPal

NOVEMBER 9, 2023

The initial RCT published on physician coaching in JAMA in 2019 showing that coaching improves quality of life. Summary Transcript Summary Coaching is in. When I was a junior faculty, coaching wasn’t a thing. We address: What is coaching? How does it differ from therapy? link] Transcript Eric: Welcome to the GeriPal podcast. Indeed, matey.

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FDA Law Blog

JULY 10, 2023

Understanding the Traditional 510(k) Review Timeline There are three types of Premarket Notification 510(k)s: Traditional , Special , and Abbreviated. Performance Metric FY 2018 FY 2019 FY 2020 FY 2021 FY 2022 Average Number of FDA Days to MDUFA IV Decision 72.62 By Philip Won & Adrienne R. But that is only the beginning.

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Provider IT Engineering Medical 75

FDA Law Blog

JUNE 23, 2021

For 6 years, I served as a patient liaison within FDA in what was then called the Office of Special Health Issues. Over the years, this function expanded to cancer (renamed the Office of AIDS and Special Health Issues) and, ultimately, all serious and life-threatening diseases (dropping the AIDS nomenclature).

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The Clinical Problem Solvers

APRIL 5, 2022

During this episode, we gained insight from special guests Dr. Margot Kushel and Mr. Bobby Watts about what brought them into their fields, how their work reaches the most marginalized, and what can be done at the community and structural level to address homelessness. Published April 5, 2019. January 18, 2019. Rothstein, R.

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