An alliance of drug companies and research advocacy groups is calling for Congress to appropriate $2.8 billion for FDA in fiscal 2018 — a $78 million increase from fiscal 2016. The additional funds would help the agency keep up with growing responsibilities and could improve food safety, drug quality and implementation of 21st Century Cures,…
Reauthorization of the FDA user fee programs is usually one of the surest bets on the congressional agenda. But not this year. These crucial agreements with drug and device makers, which provide about half of the FDA’s annual budget, are facing unusual obstacles ahead of a fall deadline for approval. And without congressional action,…
Executive Summary Existing regulatory authorities could be optimized to speed development of promising pediatric cancer therapeutics, particularly those that don’t work in adult cancers. Accelerating the development of pediatric cancer therapeutics and diagnostics will be a key focus for the US FDA’s new Oncology Center of Excellence (OCE). “As part of the newly…
A cancer patient advocate worries that President Donald Trump’s hiring freeze could put a crimp in FDA’s newly launched Oncology Center of Excellence (OCE), an initiative aimed at speeding patient access to cancer treatments and which is viewed as a possible model for creation of other disease-focused centers in the future. FDA formally launched OCE…
Key lawmakers hope to move legislation this year that aims to improve federal oversight of laboratory tests. And now two main industry groups who were previously in opposition on the issue are aligning on a strategy to lobby Congress to advance an overhaul. Laboratory developed tests, or LDTs, are currently regulated by the Centers…
Our nation’s health regulators stand at a crossroads. In one direction lies advancement through cutting-edge programs; in the other are practices that no longer reflect our best scientific insight. Health officials want to move forward, but external conditions are holding them back. President Trump can help our nation’s public health talent take the promising…
Over 30 disease advocacy groups wrote to Senate Majority Leader Mitch McConnell (R-KY) and Minority Leader Chuck Schemer (D-NY) Tuesday (Jan. 24) urging Congress to work with FDA to craft a regulatory framework for laboratory developed tests (LDTs). The groups argued that increasing LDT complexity warrants analytical validity oversight, which they feel is lacking from…
Executive Summary Industry worries about user fee programs as US FDA could wait weeks before finding out how President Trump’s hiring freeze affects it. President Donald Trump’s mandated hiring freeze for the US government, while simple on its face, could prove much more complicated in its application to FDA, meaning more confusion and uncertainty for…
On his last full day as FDA commissioner, Robert Califf announced the formation of the Oncology Center of Excellence and named Richard Pazdur its director. The process of forming the center began in June, and Pazdur has been the acting director. Reorganization of the FDA oncology portfolio is an element of the Obama White…
FDA has been working to establish a national resource for FDA-approved medical products that can be used by public and private-sector entities, including regulated industry, to conduct large scale evaluations of safety issues in an environment that is secure and protects patient privacy. These evaluations include epidemiologic studies of medical products in collaboration with multiple…
