January 2, 2019
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April 23, 2015
The amount of genetic variation between cancer patients is astounding. Two people diagnosed with cancer in the same organ may, in fact, have two very different diseases. Consequently, we are now in the middle of a transition: we no longer classify cancer based solely on its tissue of origin, but also on the key mutations…
Learn MoreMarch 16, 2015
FDA codified an expedited review pathway for breakthrough-designated drugs in a manual of policies and procedures (MAPP) released this week, instructing FDA review teams to act at least one month before the Prescription Drug User Fee Act (PDUFA) goal date for these applications. FDA confirmed it had been informally putting drugs through expedited review for…
Learn MoreFebruary 5, 2015
Dr. Margaret Hamburg, who as commissioner of the U.S. Food and Drug Administration (FDA) for almost six years has overseen public health initiatives ranging from tobacco control and food safety to personalized medicine and drug approvals, is stepping down, the agency said on Thursday. Hamburg, 59, is one of the longest-serving FDA commissioners in the…
Learn MoreFebruary 5, 2015
Margaret Hamburg has been the Commissioner of the Food and Drug Administration (FDA) since 2009. In the below entry, part 2 of 2, Dr. Hamburg discusses cher experience as Commissioner, her perspective on the FDA, and her advice for future FDA Commissioners. The interview was conducted by Ryan Hohman, Managing Director, Policy & Public Affairs…
Learn MoreJanuary 28, 2015
Days after the White House announced a new precision-medicine initiative, an influential group of US lawmakers has released its own wish list for biomedical research. On 27 January, several members of the House of Representatives released the first draft of their long-anticipated proposalto speed the translation of research into medicine. The effort, known as 21st Century Cures,…
Learn MoreDecember 30, 2014
I first Met Freda Lewis-Hall, M.D., on May 5, 2011, in New York. Pfizer’s chief medical officer had just concluded her Healthcare Businesswomen’s Association (HBA) Woman of the Year (WOTY) acceptance speech in which she challenged attendees to recommit, reenergize, and reform themselves to “be everything the patients we serve need us to be, and…
Learn MoreDecember 19, 2014
Representatives from the pharmaceutical and biotechnology industries said last Friday (Dec. 12) they expect work on the bipartisan 21st Century Cures initiative this spring to be a staging ground for negotiations over the sixth iteration of the Prescription Drug User Fee Act (PDUFA) in 2016 and 2017. Industry leaders also said they expected the biotechnology…
Learn MoreDecember 3, 2014
More than 60% of US prescriptions for cancer drugs call for using the medicines in ways that are not approved by the government. Often, they are the only hope against a fatal illness that has thwarted conventional treatments. But although such ‘off-label’ use is common, it is hard to know how effective it is because…
Learn MoreDecember 2, 2014
FDA’s evaluation of the first two years of the breakthrough therapies program found common threads among designation requests that were granted and denied, which may help sponsors better understand the agency’s criteria for awarding the incentive. Below are key characteristics of products that have gained and were denied breakthrough designation, as well as reasons why…
Learn MoreDecember 1, 2014
FDA is looking to standardize how it chooses drugs for the breakthrough approval pathway, and an early analysis of the handful of drugs chosen shows the most important criteria is that the therapy show a “spectacular advance in the field” over the typical improvement in drug development, drug center chief Janet Woodcock recently told an…
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