Exploring Access to Unapproved Therapies
In a series entitled, “When Unapproved Drugs Are the Only Hope,” Meg Tirrell of CNBC takes an in-depth look into the complicated issue of patient access to drugs that have not yet been approved by the FDA, also known as “compassionate use” or expanded access programs (EAPs). She presents the ...
Balancing Patient Protections and Innovation: NCCS Applauds FDA Action to Regulate Laboratory-Developed Tests
The National Coalition for Cancer Survivorship (NCCS) commends the Food and Drug Administration (FDA) for taking critical steps to ensure that the promise of personalized cancer medicine is realized and that cancer patients can rest assured that they are receiving treatments consistent with their diagnoses. Today, FDA notified Congress that ...
NCCS Joins Alliance for Childhood Cancer in Submitting Comments to FDA
NCCS joined the Alliance for Childhood Cancer in submitting comments to the Food and Drug Administration (FDA) following the January 2014 public workshop on complex issues in developing drug and biological products for rare diseases. The Alliance encouraged the FDA to consider the issues specific to pediatric cancers that may ...
NCCS Joins Colleagues in Offering Advice Regarding Standards for Sharing Patient-Specific Clinical Trials Data
The National Coalition for Cancer Survivorship joined colleagues in the cancer advocacy community in offering advice to the Food and Drug Administration (FDA) regarding the standards for sharing patient-specific clinical trials data with researchers. FDA has proposed that such data be made available to researchers, in hopes that such uses ...
NCCS Submits Comments in Follow-Up to FDA Patient-Focused Public Meeting
NCCS submitted comments to the Food and Drug Administration (FDA) as a follow-up to the Lung Cancer Patient-Focused Drug Development public meeting on June 28, 2013. The patient-focused drug development program is an initiative mandated by the Food and Drug Administration Safety and Innovation Act (FDASIA) and is intended to provide the ...
NCCS Joins Patient Advocate Colleagues in Commenting on FDA Document on Expedited Programs for Serious Conditions
NCCS joined its patient advocate colleagues in the Cancer Leadership Council in comments on a Food and Drug Administration (FDA) document that provides guidance about the use of certain “expedited programs” that may be employed in the review of therapies for serious conditions. The FDA has updated the guidance regarding ...
Shelley Fuld Nasso of NCCS Is Panelist at FDA Lung Cancer Meeting
Shelley Fuld Nasso, NCCS Senior Director of Policy, was a panelist at the June 28, 2013, Food and Drug Administration (FDA) meeting on patient-focused lung cancer drug development. Ms. Fuld Nasso offered advice to FDA about strategies for incorporating patient needs and preferences in lung cancer drug development. She concentrated ...
NCCS and Colleagues Comment on FDA Strategies Regarding Drug Shortages
NCCS joined colleagues in the cancer patient and provider community in providing advice to the Food and Drug Administration (FDA) regarding strategies to anticipate, mitigate, and report shortages of drugs and biologicals. In the last several years, cancer patients and many others with serious and life-threatening illnesses have experienced disruptions ...
NCCS Joins Colleagues in Offering Comments on an Alternative Approval Pathway
NCCS joined its colleagues in the patient advocate and cancer care provider community in offering comments to the Food and Drug Administration (FDA) on an alternative approval pathway for drugs to treat certain diseases where there is an unmet medical need. FDA requested public comment on a proposal that was ...
“Making Cancer Drugs Less Expensive” Linking Clinical Value to Price
In an opinion piece in the Washington Post, Hagop Kantarjian, Leonard Zwelling, and Tito Fojo offer a perspective on cancer drug prices as well as advice on how to reduce prices. In his book “Justum Pretium,” Aristotle discusses the relationship between price and worth, a topic continued 16 centuries later ...
