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…
In the Obama administration’s final days, the National Cancer Institute is establishing an ambitious new program designed to allow scientists to more quickly access new drugs and compounds for novel research. One of the last achievements of Vice President Joe Biden’s cancer moonshot initiative before he leaves office, the program was unveiled Wednesday and…
Stephen Ostroff is likely to once again take over as acting commissioner of the Food and Drug Administration when the current commissioner, Robert Califf, leaves at the end of President Barack Obama’s administration, according to the agency’s staff manual guidebook. President-elect Donald Trump’s transition team has had no contact with Califf, lobbyists say, and…
The passage of the 21st Century Cures Act at the tail end of 2016 gave precision medicine proponents and diagnostics developers reason for optimism, though detractors fear the bill gives industry players too much leeway in the name of innovation and at a cost to public health protections. Following the presidential elections and amid the…
With overwhelming support from the US Senate, and approval by President Barack Obama, the 21st Century Cures Act became law—one that will boost funding for medical research, reduce hurdles in the path of developing experimental treatments, and also support 2 huge projects that were set in motion by the current government: the Precision Medicine Initiative…
Friends of Cancer Research held an event, “The Future of the U.S. Biosimilars Market: Development, Education, and Utilization,” on Tuesday, October 18, 2016. The event was a half-day forum that brought together clinicians, originator and biosimilar drug sponsors, advocates, regulators, and payers in an attempt to tackle uncertainty surrounding the future of the United States…
Executive Summary FDA’s outgoing head of new drug review cautions against duplicating Oncology ‘Center of Excellence’ model across multiple therapeutic areas, advocating for a more ‘balanced portfolio’ in structuring review operations; other topics during podcast interview include Jenkins’ future plans in drug regulation and one major safety decision that turned out differently than expected. The…
