Real-World Evidence Accelerator Facing Data Access Challenges For Vaccines - Scrip News for Pink Sheet

The Reagan-Udall Foundation’s Evidence Accelerator program is navigating novel data flow challenges when it comes to assessing the safety and effectiveness of COVID-19 vaccines. The Evidence Accelerator was launched in April 2020 by Reagan-Udall, a foundation that supports the US Food and Drug Administration, and Friends of Cancer Research to identify key questions about the COVD-19 pandemic that could be addressed through real-world data and real-world evidence and pressure-testing approaches to address those questions.
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FDA documents shed light on chaotic COVID decision-making during Trump administration - BioCentury

Internal FDA and White House communications released by FDA in response to a Freedom of Information Act request provide a glimpse into the in-fighting, leaking and chaotic decision-making during some of the most fraught moments of the pandemic during the Trump administration.

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US FDA Eyes New Investigational Drug Label Requirements That Bring International Harmonization - Pink Sheet

The US Food and Drug Administration is considering new regulatory action to create more consistency in the labeling of investigational drugs to help reduce medication errors and protect patients as well as the integrity of the clinical trial results.

The agency is looking at recommending a harmonized global approach to the issue.

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OSE's annual report details Sentinel efforts during COVID pandemic - Regulatory Focus

The US Food and Drug Organization’s (FDA’s) Office of Surveillance and Epidemiology issued its first-ever annual report summing up the office’s work.
 
The scope of the office’s charge meant that during the pandemic, staff effort was largely directed toward addressing the global public health emergency of the COVID-19 pandemic, noted Gerald Dal Pan, director of FDA’s Office of Surveillance and Epidemiology (OSE).
 

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Listening to patients: The FDA goes from strength to strength - The Pharma Letter

Hosted by the FDA’s Office of Patient Affairs (OPA), together with the National Organization for Rare Disorders (NORD) and the Reagan-Udall Foundation, Patient Listening Sessions are small and informal conversations that bring patients/caregivers and researchers together. These sessions are aimed at complementing the FDA’s existing patient engagement initiatives.
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How to Talk to Patients Reluctant to Get a COVID-19 Vaccine - Medscape

Family physician Mitchell A. Kaminski, MD, MBA, was still awash in feelings of joy and relief at recently being vaccinated against COVID-19 when a patient's comments stopped him cold. The patient, a middle-aged man with several comorbidities, had just declined the pneumonia vaccine – and he added, without prompting, that he wouldn't be getting the COVID vaccine either. This patient had heard getting vaccinated could kill him.

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'Part of recovery is awareness': Pandemic casts harsh spotlight on industry-wide lack of diversity in clinical trials -Endpoints

Moderna emerged as an early leader in the race for a vaccine to stop Covid-19 in its tracks. The Cambridge, Massachusetts-based biotech bounded through development of one of the world’s first mRNA vaccines, but in September — when the pandemic was claiming upwards of 700 lives a day in the US — they took a step back.

The company did something not many (if any) biotechs have ever done: At the urging of the US government, they slowed Phase III enrollment to recruit more participants from minority groups.

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COVID-19 Evidence Accelerator: A parallel analysis to describe the use of Hydroxychloroquine with or without Azithromycin among hospitalized COVID-19 patients

The COVID-19 pandemic remains a significant global threat. However, despite urgent need, there remains uncertainty surrounding best practices for pharmaceutical interventions to treat COVID-19. In particular, conflicting evidence has emerged surrounding the use of hydroxychloroquine and azithromycin, alone or in combination, for COVID-19. The COVID-19 Evidence Accelerator convened by the Reagan-Udall Foundation for the FDA, in collaboration with Friends of Cancer Research, assembled experts from the health systems research, regulatory science, data science, and epidemiology to participate in a large parallel analysis of different data sets to further explore the effectiveness of these treatments.
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APhA Foundation names 2021 Jacob W. Miller Award recipient - Drug Store News

Susan Winckler, CEO of the Reagan-Udall Foundation for the Food and Drug Administration, is the American Pharmacists Association Foundation’s 2021 recipient of the Jacob W. Miller Award. The award recognizes individuals who help to advance the Foundation’s mission through their involvement and leadership in longstanding programs and new initiatives. 

Established in 2000, the award honors Jacob W. Miller who held positions in state and national pharmacy organizations and was APhA Foundation president from 1990-2000.

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