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.
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.
No comments:
Post a Comment