jueves, 27 de julio de 2017

Expanded Access Navigator to Request Single Patient Expanded Access – Register your Company’s Contact Information

FDA/CDER's Small Business and Industry Assistance (CDER SBIA)
On July 24th the Expanded Access Navigator was launched by the Reagan-Udall Foundation in collaboration with patient advocacy groups, the pharmaceutical industry, FDA, and others in the Federal government. The Navigator is an online tool to guide patients, caregivers and their physicians through the process for requesting single-patient expanded access for unapproved investigational drugs.
The Navigator explains that when a patient has a serious or immediately life-threatening disease or condition for which there is no FDA-approved treatment, they may be able to gain access to an investigational drug under the FDA Expanded Access process. Expanded Access permits the product’s manufacturer, with the authorization of FDA, to provide an investigational drug for a patient, even though the drug is still in development or under review for FDA approval.

When a physician wants to submit a Single Patient Expanded Access request to obtain an unapproved investigational drug for an individual patient, he or she must first ensure that the manufacturer is willing to provide the investigational drug for expanded access use. Thus, it is critical that physicians be able to quickly and easily contact the company sponsoring an investigational new drug when they have a patient meeting the criteria for Expanded Access.
We are requesting that companies who have not already made public their contact information and Expanded Access policy, process, or criteria, do so by completing this form as completely as possible.
For more information, please visit: The FDA Voice Blog - Expanded Access Navigator.

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