Congress averted the “fiscal cliff,” however the potential automatic spending cuts, or sequestration, has only been delayed until March 1st. These cuts will be devastating for the future U.S. leadership of research and development and would delay access to new medical treatments. Sequestration would slash federal investments in critical health, scientific, medical and biological research aimed at discovering treatments, moving safe and effective new medicines to market, and creating the innovations to grow our economy.
Patient representatives who missed the recent NIH webinar regarding the planned expansion of the NIH Undiagnosed Diseases Program may still submit input on the questions discussed.
Inside Health Posted: October 19, 2012
FDA’s preliminary list of 20 disease areas it may focus on as part of the patient-focused drug development initiative mandated by the FDA Safety and Innovation Act has led to in-fighting among patient advocacy groups that want additional diseases added, said a rare disease patient advocate who suggested FDA consider broadening the scope of the list by basing it on body systems. FDA officials tried to reassure stakeholders on Friday (Oct. 19) that the groups would have many opportunities to present their views to the agency beyond a public meeting on the issue slated for Thursday (Oct. 25).
Open To All: NIH Webinar Today To Provide Input From Patient Perspective
The NIH Office of Rare Diseases Research-NCATS and the National Human Genome Research Institute are hosting a webinar at 2:30 p.m. ET today to provide information to the patient community about a new NIH initiative to expand the Undiagnosed Diseases Program.
Friday, October 12, 2012 by MassDevice staff
Rep. Erik Paulsen tells MassDevice.com that congress wants higher user fees to come with greater accountability.
Some members of congress are calling for the FDA to provide quarterly reports on the agency’s progress toward meeting the goals set forth in the recent medical device user fee agreement.
A discussion about the power you have in political advocacy at the federal, state and local levels. One voice – yours! – makes a world of difference …
Friends of Cancer Research & the Brookings Institute:
November 14, 2012 – 8:30am- 3:00pm – The Washington Marriott – Washington, DC
Morning Keynote: Harold Varmus, M.D., Director, National Cancer Institute
Afternoon Keynote: Margaret Hamburg, M.D., Commissioner, U.S. Food and Drug Administration
New Legislation Would Provide Exclusivity Add-on for Significant Drug Combinations
By Kurt R. Karst, FDA Law Blog
Legislation co-sponsored by Representatives Brian Bilbray (R-CA), Carolyn Maloney (D-NY) and Rosa DeLauro (D-CT), and supported by the Melanoma Research Foundation, seeks to encourge the development of so-called “significant drug combinations” by offering the carrot of an extension of marketing exclusivity.
Bloomberg News: By Anna Edney on October 11, 2012
Obesity treatments, life-saving antibiotics and other drugs deemed to offer societal benefit despite their risks may get speedier U.S. approvals under plans being discussed to better balance innovation and safety.
As part of the performance commitments of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V), FDA has published a notice in the Federal Register related to Patient-Focused Drug Development, an initiative that provides for a more systematic approach to obtaining the patient perspective on certain disease areas in PDUFA V.