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

FDA Law Blog

From new initiatives to facilitate faster reviews for new indications under the Split Real Time Application Review (STAR) pilot program, to bringing new meetings under PDUFA goals, to continued support for rare diseases and incorporation of the patient voice, the goals letter revealed a good number of welcome announcements.

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Transforming the Culture of Dementia Care: Podcast with Anne Basting, Ab Desai, Susan McFadden, and Judy Long

GeriPal

He wrote a book titled “ Psychiatric consultation in long term care ” that has a strengths based approach to staging dementia (how cool is that). She directs UCSF MERI’s patient, family, and clinician support with classes and consultation on resiliency, well-being, and grief. And the person with dementia, the patient, said yes.

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Stepped Palliative Care: A Podcast with Jennifer Temel, Chris Jones, and Pallavi Kumar

GeriPal

Give too much, it may cause harm (even if the higher dose had no significant side effects, it would require patients to take a lot of unnecessary additional pills as well as increase the cost.) So, what is the effective dose of palliative care? Give too little – it may not work. Jennifer 04:25 I can take that on. Eric 05:32 Yeah.

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Grief, Loss, and Well-Being Debriefing: Vickie Leff, Matthew Loscalzo, Craig Blinderman

GeriPal

You’d imagine though that our professional expertise and experiences in helping patients and families cope with loss and grief would be helpful in managing our own personal losses. Health care professionals are human, and as humans we experience loss both in and out of work. Turns out, it’s maybe not. She was homeless. Eric: Yeah.