how to receive a drug not yet approved by the FDA
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Marion….am home from the bone marrow biopsy and not up to reading too much, so will reserve this for tomorrow. I want to print out all the information to take with me to the oncologist and hematologist….esp the latter. There is a drug soon to be approved for MDS (like maybe next month) . Has been trialed at least at MD Anderson. It is specifically for a certain mutation and has had excellent results. It’s for people whose MDS has transitioned to AML (Acute Myeloid Leukemia)…..esp if they can not do a bone marrow transplant. I’m looking forwward to reading the stuff you posted….but energy level is pretty low tonight……the sedation was “wonderful”…..no pain….asleep in 5 seconds….awake instantly…whole procedure about 10 minutes. They were fabulous at Mayo. The guy who did mine said that they do about 5000 Bone Marrow Biopsies per year there. WOW!!! Of course, that means, sadly, that there are that many very sick people that they see. Sobering thought.
Julie
Important update: FDA – The Expanded Access Navigator
The FDA released a simplified process for “physicians request to expanded access. The revised regulations were, among other things, intended to increase awareness and knowledge about expanded access and he procedures for obtaining investigational drugs for use
for patients with serious or immediately life-threatening diseases or conditions who lack
therapeutic alternatives.
This ruling apply to physicians only and differs from that of patient information provided in the above link however; I thought to link it to our site as well:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM432717.pdfHugs,
MarionSingle Patient Compassionate Use (Expanded Access) what you need to know:
Updated version:
http://www.fda.gov/downloads/ForPatients/Other/ExpandedAccess/UCM504489.pdfMarion
Expanded Access allows for obtaining a drug, not yet approved and side effects and effectiveness not yet determined in large clinical research studies. Discussing with physician is mandatory.
The following link explains in detail:Expanded Access: Information for Patients
http://www.fda.gov/ForPatients/Other/ExpandedAccess/ucm20041768.htm?source=govdelivery&utm_medium=email&utm_source=govdeliveryThis link explains further:
http://www.medscape.com/viewarticle/848017?source=govdelivery&utm_medium=email&utm_source=govdelivery
Marion
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