Please email your expanded access requests to Project Facilitate: and Familiesįor questions, please call FDA’s Division of Drug Information at 30 or email to a patient with cancer describe how Project Facilitate helped her receive an investigational therapy. Project Facilitate Expanded Access Request Submission Information Before you build your report, make sure you’re already tracking your work information in a project management tool. Project Facilitate: (240) 402-0004, Monday – Friday Īfter-hours Emergency Requests for all medical products (drugs, biologics & medical devices): call FDA's Emergency Call Center: 86 Monday – Friday after 4:30pm ET, and Weekends Project Facilitate Contact Information Healthcare Providers or Regulatory Professionals Health Care Providers or Health Regulatory Professionalsįor questions, please call Project Facilitate at (240)402-0004 (M-F, 8:00am to 4:30pm, ET) or email Expanded Access Requests to: To learn more about Project Facilitate please enjoy this short video (less than 90 seconds) The FDA Expanded Access Program allows a vast majority of these requests to proceed, and Project Facilitate is here to guide oncology healthcare providers through the process. The company has the right to approve or disapprove the physician’s request. In addition to project selections, the BRIC program offers help to communities in the form of non-financial direct technical assistance that can provide. To make a request, a member of the patient’s healthcare team will approach the pharmaceutical company to ask for its agreement that it will provide the medical product. The request process can be complex to navigate, particularly for oncologists who don’t have experience working with clinical trials or these types of requests. The investigational medical products may, or may not, be effective in the treatment of the condition, and use of the product may cause serious side effects that were not expected. Investigational medical products have not yet been approved by the FDA and the FDA has not found these products to be safe and effective for their specific use.
Project inform free#
Violence Free Colorado helps to bridge programs and the work done on behalf of survivors, provides opportunities for advocates to come together to learn and network, and gives survivors and advocates a unified voice among decision makers and funders.Oncology Center of Excellence Project Facilitate is a single point of contact call and information center created to help oncology healthcare providers or regulatory professionals submit an Expanded Access Request (also referred to as: Compassionate Use, Emergency IND, Single-Patient IND, or Pre-Approval) for an individual patient with cancer through FDA's Expanded Access Program.įDA’s Expanded Access Program allows patients with life-threatening diseases or conditions such as cancer try investigational medical products (drug, biologic, or medical device) when no satisfactory therapies are available and there is no opportunity for the patient to enroll in a clinical trial.
Meet A Coalition Meet Violence Free ColoradoĬolorado’s unique geography gives it its beauty, but can also create a sense of isolation in many communities.
Project inform download#
Download our free conversation guides, resources, and coloring pages listen to our #EmpowermentPlaylist on YouTube and Spotify check out our shareable infographics and more. Learn more about how you can get involved to end domestic violence.
Project inform registration#
These are free, open to the public, and there is no registration required. Every other Tuesday in May and June, we will be premiering the OICs live on. Join WomensLaw for our second set of Online Information Clinics (OICs), focusing on custody.
0 kommentar(er)
