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Five former FDA commissioners and dozens of patient groups have publicly asked President Donald Trump and HHS Secretary Alex Azar to nominate acting FDA Commissioner Ned Sharpless as permanent commissioner.


The endorsements come as the 210-day window for Sharpless to serve in an acting capacity is drawing to a close on Nov. 1. Azar is considering other candidates for the position, including Brett Giroir, assistant HHS secretary for health (see “Clock Ticking”).


S&P Global Market Intelligence - Former US FDA chiefs, health groups back Sharpless as permanent commissioner

Ned Sharpless, acting commissioner of the U.S. Food and Drug Administration, has won the support of five previous agency chiefs — Republican and Democratic appointees — and nearly 60 healthcare organizations to remain in the job permanently.


Under a 1998 law, Sharpless can only remain as commissioner in a temporary capacity until Nov. 1 — 210 days from the time he took the helm at the FDA. After that, President Donald Trump must submit a nomination to the U.S. Senate or appoint another acting commissioner.


Healio - Immunotherapy effective for many patients ineligible for registration trials, but caution necessary

One of the hot topics at this year’s ASCO Annual Meeting was broadening eligibility criteria to increase clinical trial access and enrollment.


Eligibility criteria are intended to ensure patient safety and define study population characteristics, but overly restrictive requirements limit the generalizability of results across broader “real-world” populations that ultimately receive the therapy.

Two studies published this spring highlight this conundrum in the context of therapy with immune checkpoint inhibitors (ICIs).


Pink Sheet - Frontiers In Real-World Evidence: US FDA Partners With Syapse To Explore Sources Beyond Electronic Records

Executive Summary

Oncology Center of Excellence will collaborate with the health data company to explore RWE sources for precision medicine.

The US Food and Drug Administration will work with Syapse Inc. to develop new real-world evidence sources outside electronic health records for various regulatory purposes.


Experts Seek Tweaks to FDA Draft Guidance on Clinical Trial Diversity

Recent US Food and Drug Administration (FDA) draft guidance on enhancing clinical trial populations’ diversity should discuss the role of real-world data/evidence (RWD/RWE), comments to FDA say.

The public comment period on FDA’s draft guidance closed with 90 submissions, including from PhRMA, Roche/Genentech, the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard (MRCT Center), the National Center for Health Research (NCHR), the American Society of Clinical Oncology (ASCO) and the National Association for Rare Disorders (NORD), among others.

COTA Collaboration: Helping FDA Figure Out What's Possible and What's Not in Embrace of Real-World Evidence

A Conversation With Chief Medical Officer Andrew Norden, MD, MPH, MBA

When it comes to generating evidence that leads to a drug approval, the randomized controlled trial (RCT) is the gold standard. The first published trial appeared in the literature more than 70 years ago,1 and over the past 30 years, the scientific community has developed the principles of evidence-based medicine,2 in which RCT results inform clinical practice guidelines.




Targeted Oncology - Although Barriers to Treating Brain Metastases Exist, Systemic Therapies Make Progress

The clinical development of treatments for breast cancer that has metastasized to the brain often stalls because of the hurdle presented by the blood–brain barrier, but preclinical literature suggests a greater emphasis on the blood–tumor barrier in the metastatic setting, said Carey K.

Regulatory Focus - FDA’s OCE Taps Syapse for Research on RWE

San Francisco-based data company Syapse said Wednesday that it has signed a multi-year research collaboration agreement with the US Food and Drug Administration’s (FDA) Oncology Center of Excellence (OCE) to work on using real-world evidence (RWE) to support regulatory decision making.



There may be no single cure, but there are nearly as many cancer treatments as there are types of the disease. Since 1975, the five-year survival rate for all cancers has risen by 36 percent. Yet researchers have struggled with a far more fundamental moonshot than developing innovative ways to treat cancer: Their challenge has been to test new treatments. Now, that might be about to change.