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Regulatory Focus - NCI’s Sharpless to Serve as Acting FDA Commissioner

The US Department of Health and Human Services (HHS) announced Tuesday that Dr. Ned Sharpless, current director of the National Cancer Institute (NCI) at the National Institutes of Health, will serve as acting US Food and Drug Administration (FDA) commissioner when Scott Gottlieb steps down next month.

 

Pink Sheet - Real-Time Oncology Review Quickly Grows Popular; Venclexta Is Latest To Join Pilot

Executive Summary

Genentech/AbbVie drug becomes the seventh product known to be pilot-testing US FDA's new pathway; our infographic details the program's goals and how it has been used so far for more efficient reviews of supplemental oncology indications.

 

Genentech Inc. is at the forefront of sponsors vying to use the US FDA Oncology Center of Excellence’s Real-Time Oncology Review (RTOR) pilot program, as the Roche subsidiary announced a second application being reviewed under the speedy new pathway.

 

Nature - Trump seeks big cuts to science funding — again

On 11 March, US President Donald Trump released his budget proposal for the 2020 fiscal year, which begins on 1 October 2019.

 

Nature’s news team reports on what Trump’s budget would mean for US government science agencies.

Associated Press - FDA Chief Dr. Scott Gottlieb Resigns

In what probably came as a surprise to many, U.S. Food and Drug Administration Commissioner Dr. Scott Gottlieb announced his resignation on Tuesday.

 

He’ll end his two-year tenure aggressively heading the agency in a month, an administration official told the Washington Post.

 

STAT - Scott Gottlieb has shown that leadership in public service is still alive and well

A lot can be said of Washington in 2019. Talk of government dysfunction and party politics clouds even the simplest conversations and policies. Working in government, once held up as a way to serve our country, has turned into a partisan attack line. But there are some exceptions.

 

Scott Gottlieb, through his deep respect for the agency he was entrusted to run, set himself apart from this political wrangling and did what was right for Americans. As he steps away from the Food and Drug Administration, he will be sorely missed.

 

Inside Health Policy - Stakeholders Pour Out Approval Of Gottlieb’s Leadership At FDA

Within hours of the announcement that FDA Commissioner Scott Gottlieb will be resigning from the agency in a month, an array of stakeholders sent out their near-universal applause of the commissioner’s leadership and policy initiatives.

 

Though representatives of industry spoke fondly of the outgoing agency chief, Michael Carome, director of the Health Research Group at Public Citizen, condemned Gottlieb for his connections to the pharmaceutical industry, said his decisions at the agency favored industry over public health, and bid him “Good riddance,” he wrote.

 

The Washington Post - FDA Commissioner Gottlieb, who raised alarms about teen vaping, resigns

Food and Drug Commissioner Scott Gottlieb, who used his post to tackle difficult public health issues from youth vaping to opioid addiction – surprising early skeptics worried about his drug industry ties – resigned Tuesday, effective in about a month.

 

Cancer Therapy Advisor - Thawing Frozen Cancer Drug Labels

As medical care rapidly evolves, there’s really no debate over the potential for drug labels to become outdated, particularly in the high stakes world of cancer treatment. The question is how best to ameliorate the problem, while still protecting the process from financial and other conflicts.

 

Cancer Network - Decreasing Clinical Trial Participation Barriers

Today we are discussing cancer clinical trial participation with Joseph Unger, PhD, MS, a health services researcher and biostatistician who is part of the public health sciences division at the Fred Hutchinson Cancer Research Center in Seattle and an assistant professor at the University of Washington’s School of Public Health. Professor Unger focuses on ways to decrease the barriers for cancer patients to enroll in clinical trials and analyzes big data to understand clinical trial participation statistics and trends.

 

Pink Sheet - Real-World Evidence Takes Courage: A Conversation With IQVIA’s Nancy Dreyer

Executive Summary

Emerging standards for regulatory use of RWE should resist the temptation to impose the standards and expectations of randomized clinical trials to a fundamentally different kind of evidence, Dreyer cautions.

 

As the 21st Century Cures Act’s vision for real-world evidence lumbers from legislation to application in the reality of regulatory decision-making, the Pink Sheet asked an expert in the use of real-world data, IQVIA Real-World & Analytic Solutions Global Chief of Scientific Affairs Nancy Dreyer, about the hurdles still ahead.

 

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