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Mastering Responses to FDA 510(k) AI Letters: A Strategic Approach

FDA Law Blog

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 Average Number of Industry Days to MDUFA IV Decision 54.69

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Episode 232: Anti-Racism in Medicine Series – Episode 15 – Housing is Health: Racism and Homelessness – Clinician + Community Perspectives

The Clinical Problem Solvers

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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Episode 275: Anti-Racism in Medicine Series – Episode 19 – Reframing the Opioid Epidemic: Anti-Racist Praxis, Racial Health Inequities, and Harm Reduction

The Clinical Problem Solvers

There is a special emphasis on the use of public health models that prioritize harm reduction and person-centered care to prevent drug-related fatalities and curb the opioid epidemic along lines of race and class. Published September 2019. Racial/Ethnic and Geographic Trends in Combined Stimulant/Opioid Overdoses, 2007–2019.

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An Arm and a Leg: The Prescription Drug Playbook, Part I

Physician's Weekly

Bob’s journey here begins in 2019 — the first day of high school for his daughter, Mary. Like I’m having to go outside of that in order to get them the medications that are nothing special. Claire: By the way, Bob asked us just to use his first name for privacy reasons. Dan: Yeah, fair.

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Private Equity Gobbling Up Hospices plus Hospice and Dementia: Melissa Aldridge, Krista Harrison, & Lauren Hunt

GeriPal

Eric: Alex, we have a super special today. We’ve got a hospice super special. Alex: We have a hospice super special day. Eric: We have a smorgasbord, if you will, of papers that got published recently around hospice, and that’s why we’re calling it a hospice super special. -@AlexSmithMD. Transcript.

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Anatomy of a Healthy Plate- Guest Blogger Rebecca Gray

New South Family Medicine and MedSpa

The world of diets and dietary theories is complicated and can be overwhelming. in-the-know/our-specials":{"type":"Static","pageId":"u7hat"},"./schedule":{"type":"Static","pageId":"tg6i2"},"./medspa":{"type":"Static","pageId":"hr7g7"},"./meet-the-team":{"type":"Static","pageId":"w0jmf"},". Food has the power to regenerate the new you!