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Category: In the News

Bloomberg Government – What to Know in Washington: Trump’s Style Risks Repelling Voters

President Donald Trump brought his chaotic and confrontational style directly to the debate stage last night during his first face-off with Democrat Joe Biden, seemingly unconcerned that his approach could alienate independent and moderate voters. Trump’s frequent interruptions and personal barbs during the roughly 90-minute showdown were the personification of his re-election strategy, which has focused largely…

The Washington Post – Seven former FDA commissioners accuse Trump administration of undermining the agency

In a rare and extraordinary rebuke, seven former commissioners of the Food and Drug Administration wrote an op-ed accusing the Trump administration of interfering politically with the agency, with potentially catastrophic effects on public trust in a coronavirus vaccine. The column, which was published online Tuesday afternoon in The Washington Post, detailed a recent pattern…

Bloomberg – FDA Official Says Vaccine Makers Know What Data the Agency Expects

The head of the Food and Drug Administration office that oversees vaccines said drugmakers developing Covid-19 shots are aware of the data that will be required to gain an emergency-use authorization, regardless of whether the agency provides formal guidance. “There’s no there there about this guidance to get excited,” said Peter Marks, director of the…

The Cancer Letter – Study of NSCLC, melanoma outcomes points to surrogacy between real-world endpoints and clinical trial endpoints

A collaboration of 10 healthcare research organizations has demonstrated that real-world endpoints can be used to describe patient outcomes that are analogous to results generated through conventional endpoints in clinical trials. The effort, drawn in part from data contributed by health IT companies with oncology portfolios, is the most recent phase of a three-year pilot…

Washington Post – FDA poised to announce tougher standards for a covid-19 vaccine that make it unlikely one will be cleared by Election Day

The Food and Drug Administration is expected to spell out a tough new standard for an emergency authorization of a coronavirus vaccine as soon as this week that will make it exceedingly difficult for any vaccine to be cleared before Election Day. The agency is issuing the guidance to boost transparency and public trust as…

PRNewswire – National Groups Call on U.S. Federal Health Agency Leaders to Stand Strong for Science Over Politics in the Fight Against COVID-19

Faith in Public Health Guidance, Vaccine, and Treatment Approval Processes Must be Restored to Overcome the Pandemic WASHINGTON, Sept. 22, 2020 /PRNewswire/ — The Alliance for Aging Research (Alliance) and 78 other national organizations representing patients, healthcare providers, and multi-stakeholder coalitions signed a letter directed to the leaders of federal health care agencies urging them…

Targeted Oncology – Ongoing Minority Underrepresentation in Clinical Research Leads to Efforts to Bridge the Divide

Inequities in patient enrollment to cancer clinical trials has once again bubbled to the surface of cancer conversations, resulting in collaboration between clinicians to address and overcome the barriers observed Of late, broad attention in the health care community has shifted toward disparities in adequate care delivery, bringing to light deep-rooted biases across fields of…

Stand Up To Cancer – Addressing Health Equity in Cancer Research and Treatment

Drs. Edith Perez, MD and Lori Pierce, MD discuss the importance of health equity, and the work SU2C and ASCO are doing to increase diversity in cancer research and treatment. “Everyone has the right to be healthy and is entitled to high-quality care,” Dr. Lori Pierce, President of the American Society of Clinical Oncology (ASCO),…

The ASCO Post – Setting an Ambitious Path to Ensure Health Equity for All Patients With Cancer

In keeping with her Presidential theme of “Equity: Every Patient, Every Day, Everywhere,” in July, ASCO President Lori J. Pierce, MD, FASTRO, FASCO, announced the Society was joining forces with the Association of Community Cancer Centers (ACCC) to increase racial and ethnic minority participation in cancer clinical trials. Studies of cancer treatment trials have showed…

The New England Journal of Medicine – Covid-19 Molecular Diagnostic Testing — Lessons Learned

On February 4, 2020, the U.S. secretary of health and human services declared that emergency use of diagnostics for SARS-CoV-2 was justified, triggering emergency authority for the Food and Drug Administration (FDA) to grant an emergency use authorization (EUA) for a device if it reasonably believes that it may be effective, rather than waiting to…