Settlement Eases Rules for Some Medicare Patients

WASHINGTON — Tens of thousands of people with chronic conditions and disabilities may find it easier to qualify for Medicare coverage of potentially costly home health care, skilled nursing home stays and outpatient therapy under policy changes planned by the Obama administration.

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Election 2012: High stakes for US science

As the election nears, the opinions of the presidential candidates diverge over research.  President Barack Obama and presidential candidate Mitt Romney often take opposing stances on government’s role in science and innovation.

Action Alert: Prevent Devastating NIH & FDA Budget Cuts

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.

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NIH Seeking Patient Input for Expansion of Undiagnosed Diseases Program

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.

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Patient Groups Spar Over FDA’s Patient-Focused Drug Development Disease List

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).

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NIH Webinar 10/17 on Expansion of Undiagnosed Diseases Program

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.

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FDA: Reps Paulsen, Eshoo call for quarterly reports on MDUFMA progress

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.

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2012 RARE Patient Advocacy Summit – Session #1 – Political Advocacy – You Have The Power!

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 …

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Friends-Brookings Conference on Clinical Cancer Research

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

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Life-Threatening Diseases Compassion through Combination Therapy Act of 2012, HR 6502

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.

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