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…
President Barack Obama Dec. 13 signed the 21st Century Cures Act, a bill that changes regulatory standards at FDA, slates additional research funds for NIH, and authorizes $1.8 million over seven years for Vice President Joe Biden’s National Cancer Moonshot Initiative. The legislation, a $6.3 billion health care reform measure designed to accelerate drug…
An industry attorney says FDA’s challenges with combination products suggest the creation of new disease-specific intercenter institutes, as called for by the 21st Century Cures law, could slow down reviews. FDA Commissioner Robert Califf recently indicated the agency is mulling how to reorganize around diseases. Language in the recently signed Cures bill requires FDA to…
Executive Summary Officials are enthusiastic about the possibility of ‘real world evidence’ supporting the regulatory process – but are also eager to tamp down expectations (or fears) that it will make a big difference any time soon. Real world evidence is definitely a “hot topic” at FDA. That phrase was used twice in one…
Executive Summary It is hard to find anything in the 21st Century Cures Act that justifies the hyperbole around its signing – or the criticism that it undermines patient safety. But, for the biopharma industry, the hype is important as a sign that pro-innovation messages have bipartisan appeal. One thing everyone in the…
