U.S. Food and Drug Administration

  • July 9, 2018  

    Conditional Approval: Right Solution for the Wrong Problem

    With: Shannon Brownlee, MS

    A Q&A with Shannon Brownlee, MS, Senior Vice President of the Lown Institute, a think tank in Boston. She is also co-founder of the Right Care Alliance, a social movement for transforming health care. Originally published April 26, 2017 Q: Musella and Tenenbaum recently proposed a new way, called conditional approval, for the American FDA to move potentially useful drugs to a patient market.… Read more »

  • July 2, 2018  

    A Proposed New FDA Drug Approval Pathway: “Conditional”

    With: Marty Tenenbaum, PhDAl Musella, DPM

    A Q&A with Al Musella, DPM, President, Musella Foundation For Brain Tumor Research & Information, Inc., Hewlett, NY, and Marty Tenenbaum, PhD, Founder and Chair, Cancer Commons, Los Altos, CA Originally published April 5, 2017 Q: The delay time from discovery/observation, through validation to approval and distribution/use of new cancer treatments remains excessive. With promising experimental treatments, advanced computer technology and biostatistics, creative alternatives… Read more »

  • April 2, 2018  

    Why Can’t Dying Patients Get the Drugs They Want? Bookmark

    Emma Shtivelman, PhD

    Excerpt:

    “At first glance, a bill passed by the House of Representatives this week seems like the kind of thing anyone could get behind.

    “Known as the “Right to Try” legislation, it would allow terminally ill patients access to experimental drugs without the approval of the Food and Drug Administration.

    “But the bill and a similar one passed last summer by the Senate do little to address the main barrier that patients face in getting unapproved treatments: permission from the drug companies themselves.”

    Go to full article published by The New York Times on Mar 23, 2018.

    If you’re wondering whether this story applies to your own cancer case or a loved one’s, we invite you to get support from Cancer Commons.

  • December 5, 2017  

    FDA Aims to Expand Early-Approval Program for Promising Drugs Bookmark

    Emma Shtivelman, PhD

    Excerpt:

    “The Food and Drug Administration wants to help patients get faster access to promising cancer treatments.

    “The agency is preparing proposals that would expand an accelerated-approval program for lifesaving medications, FDA Commissioner Scott Gottlieb told House lawmakers on Thursday.

    “Drugmakers can seek rapid conditional approval for treatments for cancer or other serious diseases based on evidence that a drug is likely to extend patient survival. Later trials once such a drug is on the market are necessary to prove the survival benefit.”

    Go to full article published by Bloomberg on Nov 30, 2017.

    If you’re wondering whether this story applies to your own cancer case or a loved one’s, we invite you to get support from Cancer Commons.