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Update on CDER, CBER, and CDRH Meetings with Industry

FDA Law Blog

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — On May 11, 2023, the U.S. The pandemic also deeply impacted how industry and the government conduct their operations. CDER and CBER CDER and CBER announced they would resume in-person face-to-face (FTF) industry meetings on February 13, 2023.

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Logistics Unwrapped: A Roadmap to Successful FDA Meetings in In-Person and Hybrid Formats

FDA Law Blog

If you are driving, stop at the vehicle screening facility and inform security that you are attending a meeting. Inside Building 66 Upon arriving at Building 66, all visitors must present government-issued photo identification for check-in. The video equipment dynamically followed the speakers and presented them on the screen.

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Welcome to SRP-RMT – Standardization Comes to Regenerative Medicine Therapies?

FDA Law Blog

Lewis, Senior Regulatory Device & Biologics Expert — On October 20, 2023, FDA announced the availability of the final guidance authored by CBER titled “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies.” Tobolowsky & Richard A. It finalized a draft guidance published in 2022.

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Anti-Asian Hate: Russell Jeung, Lingsheng Li, & Jessica Eng

GeriPal

Ongoing reports from patients about anti-Asian hate experiences Should clinicians screen for Anti-Asian hate? question used to screen for domestic violence. It’s both institutionalized racism where there are policies and practices by corporations, by government that create inequality. Eric 31:19 Yeah.

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Aging and Homelessness: Margot Kushel

GeriPal

In terms of their risk, in terms of how we think of preventive health, as we think of screening, all of those things, I would turn around to the geriatricians and say, “Check your implicit bias. In the United States in 2023, the truth of the matter is you don’t need very many individual risk factors to become homeless.

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Guiding an Improved Dementia Experience (GUIDE) Model: A Podcast with Malaz Boustani and Diane Ty

GeriPal

So I thought… And I was doing this for the United States Preventive Services Task Force because we were looking at the evidence to what’s the benefit and harm of screening, and I had to look all over. Just to let you know, Eric, we have to give the credit to our federal government. Diane: Yeah. Malaz: Yeah. Diane: Innovate.

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Episode 285: Anti-Racism in Medicine Series – Episode 21 – Psychosocial and Cultural Considerations for Providing Healthcare to Immigrant and Refugee Populations

The Clinical Problem Solvers

Gillette” Gillette-Pierce May 2, 2023 Summary: This episode highlights the psychosocial and cultural considerations for providing healthcare to immigrant and refugee populations. April 25, 2023 Show Transcript Download CPSolvers App here RLRCPSOLVERS