The non-profit Reagan-Udall Foundation said it elected Ellen Sigal as chairman and Richard Schilsky as vice chair of its board of directors. Sigal, who has been acting chair since 2015, is the founder of advocacy group Friends of Cancer Research. Schilsky is SVP and CMO of the American Society of Clinical Oncology (ASCO). He has…
An FDA “Breakthrough” tag, which has been around since 2012, was once a highly coveted badge that in essence allows the regulator to help speed up development of new meds, and it was believed initially that these would be fairly rare occurrences held back for some truly innovative treatments. Now, however, the FDA seems…
The FDA backed off from a plan to issue final guidance for the regulation of laboratory developed tests (LDTs). “We have been working to develop a new oversight policy for laboratory developed tests, one that balances patient protection with continued access and innovation, and realize just how important it is that we continue to work…
Biopharmaceutical companies no longer consider FDA an obstacle to innovation and in need of major reform, according to leading observers of the drug regulatory process. “We now have clear expectations about review times,” said Jim Greenwood, president of the Biotechnology Innovation Organization (BIO), at a forum sponsored by the Bipartisan Policy Center. So we “don’t…
The head of the National Institutes of Health (NIH) is warning that plans to pass a short-term government spending bill could deal a blow to health research. NIH Director Francis Collins on Thursday called the plan for a continuing resolution (CR), which would extend current spending levels until March, “an extremely unfortunate and painful…
The head of the National Institutes of Health (NIH) warned that postponing Congressional action on major spending bills until 2017 — as GOP leaders have said they will do — puts agency programming at risk. Along with other advocates and industry representatives at a Bipartisan Policy Center briefing on Thursday, he lobbied for passing a…
Executive Summary US FDA commissioner and others say they have put disagreements from controversial decision to approve Sarepta’s Duchenne muscular dystrophy drug behind them. FDA entrance sign 2016 FDA’s controversial approval of Sarepta Therapeutics Inc.’s Duchenne muscular dystrophy drug Exondys 51 elicited emotional disagreements among FDA staff, but officials maintain that they have largely been…
When I lost my only sister to breast cancer in 1986, patients like her had devastatingly few choices. Over the intervening decades, sustained commitment to biomedical research at the National Institutes of Health (NIH) and major technologic advances have led to transformative changes in cancer research and treatment. Advanced therapies and protocols have boosted survival…
Executive Summary US FDA, CMS and NIH are hoping to create a “single front door” for research. Article outlining collaboration on real-world evidence suggests one path forward. The heads of FDA and CMS are outlining a vision for collaboration on development of real-world evidence ahead of the transition to a new presidential administration. …
Executive Summary After a record-setting 2015 for new drug approvals, there were not enough applications with user fee goals in 2016 to reach that level again. FDA’s approval metrics could not remain at record levels forever, and it now appears the regression toward the mean has begun. Office of New Drugs Director John…
