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Change is Inevitable – Plan Ahead: An Assessment of FDA’s Draft Guidance on Predetermined Change Control Plans for Artificial Intelligence/Machine Learning-Enabled Device Software Functions

FDA Law Blog

Manufacturers should be able to verify and validate the proposed modifications within their existing quality system. Post-market, manufacturers can make modifications consistent with the PCCP and document the modification in accordance with their quality system, without the need for a new marketing submission.

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The FDA PDUFA VII Goals Letter (FY 2023-2027): A Review of Our Top 10 Commitments

FDA Law Blog

When FDA published the fiscal years (FY) 2023-2027 goals letter at the end of August, making known their commitments and planned initiatives for the coming years, we were both excited by many of the announcements, while recognizing the real success will come from how the Agency implements them. Livornese and Josephine M.

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Episode 309 – Antiracism in Medicine Series – Episode 23 – Anti-Blackness, Anti-Fatness, and Food Shaming

The Clinical Problem Solvers

Siddiqui October 31, 2023 Summary : This episode highlights the culture of food shaming and anti-fatness as it relates to anti-Blackness. Identify ways to navigate clinical interactions with patients while respecting them and affirming their experiences with food and fatness. 2023, September 21). is rooted in anti-Blackness.

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Psilocybin in Serious Illness: James Downar, Ali John Zarrabi and Margaret Ross

GeriPal

Summary Transcript CME Summary Weve covered psychedelics on the podcast beforefirst in 2019 with Ira Byock, where we explored their potential role in medicine , and then again in 2023 with Stacy Fischer, Brian Anderson, and Theora Cimino, focusing on the reasons to approach psychedelic use in patients with caution. James 00:32 Good afternoon.

Illness 107
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MedTech Conference Download

FDA Law Blog

If you have a good relationship with the review team, Dr. Maisel encourages a brief phone call or quick email to obtain informal feedback. In closing, he advised manufacturers who plan to market their products beyond the public health emergency to plan to submit marketing applications. Another is to improve submission quality.

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