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Vaccine Uptake Strategies & Ethical Considerations- Part II

Integrated Care News by CFHA

WHO grouped these determinants into contextual, individual, and group influences and vaccine/vaccination-specific issues. There is an ongoing debate about the ethics of utilizing nudges in policy and health care that focuses on whether nudging undermines autonomy and whether it could be ethically justified even if/when it does.

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Episode 148: Antiracism in Medicine Series Episode 4 – Dismantling Race-Based Medicine Part 2: Clinical Perspectives

The Clinical Problem Solvers

19:05 Clarifying the “ethics vs science” argument and critiquing research techniques 22:00 Resurgence of race-based speculation in COVID-19-related research 25:57 Implantation of ideas about innate racial inferiority within medicine 28:32 Will removal of race from algorithms potentially harm our patients?

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Let’s Listen to Patients: FDA Releases Final Guidance on Patient Engagement in the Design and Conduct of Medical Device Clinical Studies

FDA Law Blog

Bauer, Senior Regulatory Drug Expert — Our readers probably know that we value and advocate for patient engagement as an essential component in the development of medical products (see our firm’s commitment here ).

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Screening for Dementia: A Podcast with Anna Chodos, Joseph Gaugler and Soo Borson

GeriPal

Joseph Gaugler is the Director of the Center for Healthy Aging and Innovation at the University of Minnesota, director of the BOLD Public Health Center of Excellence on Dementia Caregiving, and Editor-in-Chief of the Gerontologist. What should we use to screen individuals? Who should get it if anyone? Is that right, Soo?

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It Takes Three [Components] to Make a Thing Go Riiiiiight – OPDP Challenges Two-Part Ad

FDA Law Blog

Speaking from a bit of experience, this has led to countless field direction memos instructing sales reps on how to pivot from their opening disease awareness presentations to their product details in an effort to keep these two types of communications separate. Creating TV commercials ain’t cheap nor is the air time for them.

IT 40
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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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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

Together, our guests explore and unpack how the criminalization and racialization of substance use builds to the present-day opioid epidemic and shapes inequities in care. Between 2007 – 2019, Black individuals experienced a higher death rate for opioid overdose deaths than any other racial or ethnic group.