Didanosine

Note: The following information is to be used by physicians who would like to request an Emergency IND for an antiviral product regulated by the Center for Drug Evaluation and Research (CDER)/Division of Antivirals (DAV). DAV regulates products that are being developed to treat infections caused by viruses (e.g., influenza, hepatitis B, human immunodeficiency virus 1 [HIV-1], and adenovirus). Emergency IND requests for products not regulated by CDER/DAV should be directed to the appropriate point of contact for the FDA Center/Division in which the product is reviewed. For questions on who to contact and a list of CDER Review Division contact information, please see the link below entitled “For Physicians: How to Request Single Patient Expanded Access." If the appropriate CDER review Division is unknown, please contact the Division of Drug Information at 301-796-3400 or 855-543-3784 , 301-431-6353 (fax) and druginfo@fda.hhs.gov . CBER Contact Information: 800-835-4709 or 240-402-8010 A physician may decide to request use of an investigational antiviral product through a single-patient Emergency Investigational New Drug (EIND) application if: the physician considers the product may be urgently needed for the patient’s serious or life-threatening condition; no satisfactory alternative therapy is available; and the patient cannot receive the product through any existing clinical trials or expanded access protocols For general information about single-patient use of investigational products, see: HOW TO REQUEST AN EIND for an investigational drug product regulated in the FDA/CDER/Division of Antivirals (treating physician has determined that the probable risks and benefits to the patient are appropriate) 1. Contact sponsor/manufacturer to ensure that the manufacturer is willing to provide the investigational product for EIND use (note: Letter of authorization from sponsor/manufacturer granting a right of reference to the information in their existing IND must be submitted to FDA at time of formal EIND application submission [by day 15]) 2. If the manufacturer agrees to provide drug, call or email to obtain FDA authorization for the EIND use (forms/information to support the use will be requested by FDA and can be provided via phone, fax or email; see required forms/information below): During regular business hours* (8:00 am – 4:30 pm Eastern Time Monday-Friday), call DAV at 301-796-1500 . You may also email your request to DAVPEINDREQUEST@fda.hhs.gov . *If you are unable to reach DAV, contact CDER’s Division of Drug Information (DDI) at phone: 301-796-3400 or 855-543-3784 ; fax: 301-431-6353 ; or e-mail: druginfo@fda.hhs.gov . If DAV and DDI are not available, contact the CDER Emergency Coordinator (CEC) of the Counter-Terrorism and Emergency Coordination Staff (CTECS) at phone: 301-796-9900 or 301-796-2210 ; fax: 301-431-6356 ; or e-mail at: CDER-EIND@fda.hhs.gov . After regular business hours (weekdays after 4:30 pm or before 8:00 am Eastern Time; weekends or holidays), once you have contacted the supplier of the investigational product, please call the CEC phone number ( 301-796-9900 ) and email CDER-EIND@fda.hhs.gov to pursue FDA EIND authorization. 3. Complete the following required forms: Form FDA 3926 can be used by physicians when submitting requests for individual patient expanded access to investigational drugs, including in emergencies. This form is designed specifically for single patient IND requests. It can also be used for certain submissions to FDA after the initial application is filed ( if you have trouble opening this form you may need to open it in Internet Explorer or right click on the form and save it as a PDF ). For more information, including instructions, please visit the guidance Individual Patient Expanded Access Applications: Form FDA 3926 . ---------OR----------- Form FDA 1571 (PDF - 221KB) and Form 1572 (PDF - 208KB) : Physicians are still able to use Investigational New Drug Application Forms 1571 and 1572 for single patient expanded access submissions; however, Form 3926 is developed specifically for these requests and should be easier to complete. Note: Forms FDA 1571 and 1572 are still required for other expanded access submissions (e.g., intermediate access or treatment INDs) and for IND submissions by commercial sponsors or drug manufacturers. Form FDA 1571 (Instructions) Note: More specific patient information may be required depending on the drug product being requested. If this is the case, you will be notified and provided the appropriate patient information form. In addition to the required forms listed above, include a Curriculum Vitae (CV) of the Sponsor (the attending physician or fellow, not a resident) of the EIND. If the person requesting the EIND is not the sponsor-investigator, the requestor must know the name and contact information of the sponsor investigator who will sponsor the IND and patient history information (age, sex, weight, laboratory values, concomitant medications). 4. Send the completed required forms to DAV by fax 301-796-9883 or e-mail ( DAVPEINDREQUEST@fda.hhs.gov ). Please include telephone and fax numbers where you can be reached in case we have additional questions or need additional information to support granting of the EIND. If you send the paperwork by fax, please call the Division ( 301-796-1500 ) to inform us the fax has been sent. If your request is received during business hours, you will be contacted by our Regulatory Project Management Staff. If granted, an EIND number will be assigned and provided to you. Please provide the EIND number to the drug manufacturer for release of the drug. If your request is received after business hours, you will NOT be given an EIND number if your request is granted. Provide the drug manufacturer with the name of the person who authorized the EIND for release of the drug. A member of our Regulatory Project Management Staff will follow up with you the next business day to request any additional information needed to complete your request and to provide you with an EIND number. Please provide the EIND number to the drug manufacturer. 5. If the EIND is granted or if your initial written submission was incomplete (missing CV or Letter of Authorization), mail the paperwork within 15 days (Form 3926 (or 1571/1572), CV, Letter of Authorization) one original and two (2) copies to: Food and Drug Administration Center for Drug Evaluation and Research Central Document Room ATTN: Division of Antivirals “Expanded Access Submission” 5901-B Ammendale Road Beltsville, MD 20705-1266 6. At the conclusion of product use (whether because of completion/discontinuation of treatment, if the patient dies, or if you have decided not to treat this patient with this investigational product) , please submit a request to withdraw the EIND, along with FDA Form 1571/1572 or FDA Form 3926, to the address above. Please include information on the results of the treatment, and the disposition of any unused supplies of the drug. In addition, if treatment is interrupted because the patient experienced an adverse reaction while receiving therapy that leads to discontinuation, we recommend that you follow the patient until the event is resolved, then submit your withdrawal request and include information on the patient and adverse experiences. Note: Sponsors or institutions contemplating repeated EIND requests for the same product should give early consideration to submission of an IND protocol into which multiple patients can be enrolled, rather than relying on multiple individual-patient EINDs. Division of Antivirals Phone: 301-796-1500 Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.