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On June 2, 2016, the Food and Drug Administration (FDA) issued three final guidance documents related to access to investigational therapies for patients with serious or immediately life-threatening medical conditions who lack therapeutic alternatives.
The first guidance, Individual Patient Expanded Access Applications: Form FDA 3926, describes a streamlined option for licensed physicians to request use of an investigational new drug to treat individual patients who have exhausted other treatment options, including for emergency use. When this form is substituted for the current forms FDA 1571 and 1572, the agency estimates that each submission will take about 45 minutes, which is considerably less time than is required by the current forms.
The second guidance, Expanded Access to Investigational Drugs for Treatment Use—Questions and Answers, responds to frequently asked questions about the implementation of FDA’s regulations on expanded access to investigational drugs.
The third guidance, Charging for Investigational Drugs under an IND—Questions and Answers, provides information for the pharmaceutical industry on frequently asked questions about the implementation of FDA’s regulations related to charging for investigational new drugs in the context of clinical trials or expanded access for treatment.
These documents are intended to simplify and clarify expanded access to help health care professionals, patients, and industry more easily navigate the process and to facilitate patient access to potentially life-saving medications. The FDA has also developed patient and physician fact sheets about expanded access and will host a webinar for health care professionals on July 12th at 1 PM ET to further explain the expanded access process. Information about the webinar will be posted on the FDA website.
On June 2, 2016, the Food and Drug Administration (FDA) issued three final guidance documents related to access to investigational therapies for patients with serious or immediately life-threatening medical conditions who lack therapeutic alternatives.
The first guidance, Individual Patient Expanded Access Applications: Form FDA 3926, describes a streamlined option for licensed physicians to request use of an investigational new drug to treat individual patients who have exhausted other treatment options, including for emergency use. When this form is substituted for the current forms FDA 1571 and 1572, the agency estimates that each submission will take about 45 minutes, which is considerably less time than is required by the current forms.
The second guidance, Expanded Access to Investigational Drugs for Treatment Use—Questions and Answers, responds to frequently asked questions about the implementation of FDA’s regulations on expanded access to investigational drugs.
The third guidance, Charging for Investigational Drugs under an IND—Questions and Answers, provides information for the pharmaceutical industry on frequently asked questions about the implementation of FDA’s regulations related to charging for investigational new drugs in the context of clinical trials or expanded access for treatment.
These documents are intended to simplify and clarify expanded access to help health care professionals, patients, and industry more easily navigate the process and to facilitate patient access to potentially life-saving medications. The FDA has also developed patient and physician fact sheets about expanded access and will host a webinar for health care professionals on July 12th at 1 PM ET to further explain the expanded access process. Information about the webinar will be posted on the FDA website.
On June 2, 2016, the Food and Drug Administration (FDA) issued three final guidance documents related to access to investigational therapies for patients with serious or immediately life-threatening medical conditions who lack therapeutic alternatives.
The first guidance, Individual Patient Expanded Access Applications: Form FDA 3926, describes a streamlined option for licensed physicians to request use of an investigational new drug to treat individual patients who have exhausted other treatment options, including for emergency use. When this form is substituted for the current forms FDA 1571 and 1572, the agency estimates that each submission will take about 45 minutes, which is considerably less time than is required by the current forms.
The second guidance, Expanded Access to Investigational Drugs for Treatment Use—Questions and Answers, responds to frequently asked questions about the implementation of FDA’s regulations on expanded access to investigational drugs.
The third guidance, Charging for Investigational Drugs under an IND—Questions and Answers, provides information for the pharmaceutical industry on frequently asked questions about the implementation of FDA’s regulations related to charging for investigational new drugs in the context of clinical trials or expanded access for treatment.
These documents are intended to simplify and clarify expanded access to help health care professionals, patients, and industry more easily navigate the process and to facilitate patient access to potentially life-saving medications. The FDA has also developed patient and physician fact sheets about expanded access and will host a webinar for health care professionals on July 12th at 1 PM ET to further explain the expanded access process. Information about the webinar will be posted on the FDA website.
