Tag Archive for: FDA

WCOE: Replacing the SGR Formula, Patient Advocate Speaks at FDA, and Dr. Peter Ubel talks Patient Needs

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#Medicare, replacing the SGR forumula, and the need for quality measures via @sarahkliff https://t.co/LP8CmO69gX — NCCS – National Coalition for Cancer Survivorship (@CancerAdvocacy) April 6, 2015 Shirley Mertz spoke at FDA Pt-Focused Drug Development Mtng. https://t.co/t4sHSiWLWQ Passionate! pic.twitter.com/XdSDrTekx0 — MetastaticBCNetwork (@MBCNbuzz) April 3, 2015 Dr. Peter Ubel (VIDEO) "If we assume that we know what […]

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WCOE: Pace of FDA Drug Approvals, Redesigning Insurance Exchanges, Shared Decision Making, and Thoughts on Data Collection

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Too Fast, or Too Slow? Public disagrees over pace of #FDA's new drug approvals https://t.co/gnvqJq56AH via @RAPSorg — ResearchAmerica (@ResearchAmerica) February 25, 2015 Everything I know about a good death I learned from my cat https://t.co/KeC5qEcynk — Shelley Fuld Nasso (@sfuldnasso) February 25, 2015 A Faster Way to Try Many Drugs on Many Cancers https://t.co/EFms6hYq3d […]

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NCCS Policy Comments: FDA’s Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)

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NCCS submitted comments to the Food and Drug Administration (FDA) on the Draft Guidance: Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs).  We support the FDA’s efforts to develop a strong regulatory framework for LDTs and commend the agency for the open and transparent process it has pursued in developing the framework and receiving […]

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Announcing a New Blog Series: “The Imperatives for Quality Cancer Care” 20 Years Later

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Read posts from the new blog series: “The Imperatives for Quality Cancer Care” 20 Years Later In 1995, NCCS published Imperatives for Quality Cancer Care: Access, Advocacy, Action, and Accountability (Imperatives), the culmination of an inclusive, community-based process.  Adopted at the First National Congress on Cancer Survivorship, the Imperatives represented the community’s first look at […]

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WCOE: New IOM Report, Control Issues, Tempting Treatment Options, and Patients ‘Right to Try’ New Drugs

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New IOM Report: Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risks https://t.co/neRjKfx8ma #datasharing — NASEM Health (@NASEM_Health) January 14, 2015 "Cancer survivors plagued by lack of personal control" https://t.co/9tRPQrbdzs via @reuters "a wish to return to 'normal'" — NCCS – National Coalition for Cancer Survivorship (@CancerAdvocacy) January 14, 2015 Doing More for Patients Often Does […]

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WCOE: FDA News, Medical Debt, the ACA, and Honoring Jessie Gruman

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Why The FDA Panel's Nod To Sandoz's Filgrastim (Zarzio) Is Good News For Patients, by @ElaineSchattner – https://t.co/Dle8xM2G9I — Elaine Schattner MD, MA (@ESchattner) January 8, 2015 NEW Policy Insight: High cost sharing can contribute to medical debt. Transparency can help consumers avoid it: https://t.co/p4uh62kkVd — KFF (Kaiser Family Foundation) (@KFF) January 8, 2015 Amid […]

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NCCS Policy Comments: Recommending Cancer Survivorship as a Topic for FDA Patient-Focused Drug Development Meetings

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Last week, NCCS submitted comments to the U.S. Food and Drug Administration (FDA) regarding the series of patient-focused drug development meetings that have been convened and the list of disease topic meetings scheduled for 2016-2017. In 2013, FDA convened a patient-focused drug development meeting related to lung cancer and has plans to convene a breast […]

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NCCS Offers Policy Comments: Strategies for Increasing Patient Participation in FDA Review Activities

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The Food and Drug Administration Safety and Innovation Act (FDASIA) authorized a patient-focused drug development program, and in the years since enactment, the U.S. Food and Drug Administration (FDA) has implemented certain initiatives of the patient-focused program. In recent weeks, FDA has requested feedback regarding patient-focused activities to date and recommendations about future efforts and […]

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WCOE: Brittany Maynard’s Death with Dignity, Election Results and the ACA, and Susan Gubar’s “Not Talking About Medical Mistakes”

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Brittany Maynard, a 29-year-old woman with brain cancer who became an advocate for the “death with dignity” movement took her life this week. Marcia Angell wrote about “The Brittany Maynard effect: How she is changing the debate on assisted dying” in The Washington Post, as did Sarah Kliff in “Brittany Maynard and the debate about […]

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Incremental Improvements Are Not Enough

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Two years ago, the world lost an extraordinary person, my dear friend Dr. Brent Whitworth. He was a few days shy of his 42nd birthday when he learned of his diagnosis – stage IV kidney cancer – and he was devastated. He had surgery at a major cancer hospital and then entered a clinical trial […]

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