Executive Summary Oncology Center of Excellence Director Richard Pazdur says agency invites sponsors to present about molecules under development to learn more about future plans. The US FDA’s oncology review division is receiving previews of products in development from sponsors, in part so they can understand their goals beyond the next application. Richard Pazdur,…
Executive Summary Rachel Sherman says agency is creating patient affairs staff, but will not undergo reorganization to create an official office. The US FDA’s new patient affairs office will not be an actual “Office” in the official sense of the word, but will remain a group working to help patients and advocates find their way…
Executive Summary US FDA not looking to reduce attendance at third-party patient meetings, which deliver ‘bang for the buck.’ Excessive sweating is first externally led PFDD meeting for a more common condition. Drug sponsors interested in hyperhidrosis research and development should focus on treatments that are effective for all types of excessive sweating…
When diagnosed with Hodgkin lymphoma at the age of 33 years, FDA Commissioner Scott Gottlieb, MD, was told he had a 90%chance of survival. “Ninety percent doesn’t sound so good if it’s you,” Gottlieb, now 44, told HemOnc Today following a keynote presentation at the Friends of Cancer Research Annual Meeting. “So, to me, that…
The topic of cancer drug labels and how they can be updated more quickly, as well as how the labeling system needs to be reformed was front and center at several panels at the Friends of Cancer Research’s annual meeting in Washington, D.C. on Wednesday. Janet Woodcock, director of the US Food and Drug…
Executive Summary Deputy Office of New Drugs director says IND evaluation and post-market surveillance could be part of restructuring effort along with changes to application review. The US FDA’s restructuring of the Office of New Drugs could extend well beyond new drug application reviews. Changes to many of its pre- and post-market business practices also…
Executive Summary US guidances will be shorter and use a series of bullet points to communicate key ideas, replacing the current longer and wordier format. FDA is embracing the short bulleted list to communicate its thinking about drug development going forward. Rather than continue issuing guidances that are riddled with legalese, long paragraphs and…
A top White House health official defended HHS’ recent regulation to make dramatic cuts to a federal drug discount program despite pushback from lawmakers and hospital groups The 340B program is “incredibly flawed in how its operating,” OMB Associate Director for Health Programs Joe Grogan said this afternoon at Prevision Policy Friends of Cancer Research…
In a recent forum, oncology professionals explored how precision medicine can help cancer patients by ensuring that diagnostic tests for somatic mutations in oncology are accurate and meet certain analytical performance standards. Organized by the Friends of Cancer Research (FOCR) and Alexandria Real Estate Equities, Inc., in Washington, DC, the event was the sixth “Blueprint…
Food and Drug Administration Commissioner Scott Gottlieb is considered to be a leading contender to succeed Tom Price as Health and Human Services secretary. While many, including Republicans in Congress, think he is qualified for the promotion, many of his fans and allies would lament his departure from FDA. In the five months since…
