Just a few days after a report surfaced noting that HHS Secretary Alex Azar was pushing for controversial secretary for health Brett Giroir to take the helm at the FDA from acting chief Norman “Ned” Sharpless, a new report has surfaced noting some high-profile support gathering in Sharpless’ corner. This time the messenger was The…
The jockeying over who will be the next Food and Drug Administration commissioner intensified Tuesday when former agency heads and dozens of health groups urged the White House to nominate acting FDA chief Norman “Ned” Sharpless to become the agency’s permanent commissioner. Supporters of Sharpless sent two letters — one from four former FDA…
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…
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…
Dive Brief: After holding a series of meetings with stakeholders and adding Sen. Richard Burr, R-N.C., as a new lead sponsor, Congress is working toward releasing an updated Leading-edge IVCT Development, or VALID, Act in the coming months, multiple sources familiar with the issue told MedTech Dive. The legislation, which aims to overhaul how in…
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…
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. FDA’s Oncology Center of Excellence and Syapse announced a…
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…
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…
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. Syapse and OCE will work with EHRs, labs and registries, among other data…
