Friday, December 18, 2015

FDA’s compassionate use application process

Just in case you find something for your rehab. I highly doubt that you can get THC, cannabinoids or marijuana this way.
http://medcitynews.com/2014/12/fdas-compassionate-use-process-needs-efficient-beats-right-beg-laws-pased-states/?utm_source=MedCity+News+Subscribers&utm_campaign=0053a995ad-RSS_EMAIL_CAMPAIGN&utm_medium=email&utm_term=0_c05cce483a-0053a995ad-67013357

Understanding Expanded Access/Compassionate Use

What You and Your Healthcare Provider Need to Do Before Requesting Expanded Access/Compassionate Use?

Before you or your healthcare provider contact FDA to request Expanded Access to an IND you will need to:
  • Search for possible clinical trials you may qualify for by using our clinical trials search tool or visiting ClinicalTrials.gov.
  • Search for specific expanded access programs through an online search engine.
  • Call drug/device companies directly to ask about their policies.
  • Contact patient advocacy organizations to see if they have information on expanded access programs.
  • If your healthcare is managed by anyone other than a physician you will need to find a physician who is willing to oversee therapy with a drug s/he is not familiar with, and to work with the company and FDA to obtain the drug, monitor you, and file necessary paperwork. Only a licensed physician is able to apply for expanded access. 
Talk with your healthcare provider to see whether use of an investigational drug/device for your treatment is right for you. Be sure to consider how much is known about the investigational drug/device, the severity of your condition, and the likelihood that the therapy will be effective. You and your healthcare provider should consider the kind of illness you have, the stage of disease, other conditions you may be experiencing, and organ function (e.g., liver and kidney function), among other factors.
If you still have questions unanswered or just want to understand the process more contact us, the FDA Office of Health and Constituent Affairs at PatientNetwork@fda.hhs.gov.

What are the Different Types of Expanded Access/Compassionate Use?

FDA regulations have allowed patients allowed access to investigational drugs and biologics through expanded access since 1987. The FDA currently approves expanded access:
  • on a case-by-case basis for an individual patient.
  • for intermediate-size groups of patients with similar treatment needs who otherwise do not qualify to participate in a clinical trial.
  • for large groups of patients who do not have other treatment options available, once more is known about the safety and potential effectiveness of a drug from ongoing or completed clinical trials.
It is important to remember that the company that is developing the drug/device need to approve your request. Without the companies approval expanded access to an IND cannot happen. Expanded Access can be approved for you in an emergency situation and this is known as an emergency IND. This type of request can be made over the telephone by your physician and approved by a FDA authorized official at the same time.  The drug/device can be shipped before the written request (this needs to be sent after the telephone request) is received by FDA.

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