fda contact directory

Favorable answers alone provide no guarantee that Pharvaris will be able to provide pre-approval access to an experimental medicine. Ascendis Pharma will not incentivize the healthcare provider (HCP) in any way for accessing any Investigational Treatment. let formElement = document.getElementById("tfa_0"); The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. }); Leadership profiles, major initiatives, speeches, testimony and more, An official website of the United States government, : Deputy Associate General Counsel (Drugs and Biologics . Food and Drug Division | HHS.gov Xynomic will only provide abexinostat tablets. Have undergone standard treatments without success and no comparable or satisfactory alternative treatment is available or exists to treat the disease or condition. Before sharing sensitive information, make sure you're on a federal government site. FDA's reorganization reflects the agency's commitment to modernizing its structure to advance its mission to protect and promote public health, and to meet the challenges of rapid innovation across the industries regulated . Always speak to your health provider about the risks and benefits of FDA-regulated products. Real Sagkahan, Calanipawan Road, Tacloban City(053) 888-1806 / 09532203817, IV. Generally, patient eligibility for consideration of treatment with Investigational Therapy include, but not limited to: Patient must be diagnosed with either a serious, debilitating, or life-threatening medical condition. Provide vison, leadership and strategic direction for the Center regarding engagement with international regulatory authorities to promote alignment in regulatory requirements. Be an adult male with a confirmed diagnosis of X-linked adrenoleukodystrophy. formElement.addEventListener('submit', appendJsTimerElement, false); Ruth P. Dixonruth.dixon@fda.hhs.gov A treating physician, who is able to comply with the requirements that are stated in this document, may request information about how to apply for access to Xynomic investigational products by contacting the Company. Through rulemaking, the FDA established a process in 21 CFR 170.39 by which a manufacturer can request a threshold of regulation exemption. USDA-Employee Directory Regulatory requirements have been completed based on local IRB requirements, such as compassionate use. FdA corporate office is located in 5 Plaza De Las Cortes Piso 7, Madrid, Madrid, 28014, Spain and has 31 employees. Patients with severe liver disease as defined by Child-Pugh Class C. Patients who are eligible and are able to participate in a clinical trial of Voriconazole Inhalation Powder. Many perspectives, one voice, since 1896. White Oak Building 31, Rm. I. We share the urgency of patients seeking new treatments for potentially life-altering diseases, and understand the interest in accessing our therapies outside of clinical trials and prior to regulatory approval. Directories Directory of State and Local Officials Search regularly updated contact information for state and local regulatory officials involved with food, animal feed, animal health, and food defense. Venatorx Pharmaceuticals (the Company) is focused on conducting clinical studies and obtaining regulatory approval of investigational medicines in support of its mission to develop safe and effective treatments for infectious diseases. Government Offices FDA Offices Illinois There are 9 FDA Offices in Illinois, serving a population of 12,854,526 people in an area of 55,505 square miles. Join the newsletter to stay informed about the latest food and medical products related news from AFDO, Jurisdiction and Enforcement Authority Directory, Retail Food Regulatory Programs Directory, IFSS Food Protection Professionals Curriculum Framework General Education Courses, Being human in the age of digital innovation, AFDO cyclospora: part two regulatory approach, Food service risk-factor violation trends, Find jurisdiction and enforcement authorities. }; Saskatchewan Vaxxinity is committed to developing safe and effective immunotherapeutic vaccines, with a goal of providing our next generation products as soon as possible through efficient product development. Suitable treatment options are not available to treat the ongoing condition OR the patient has a documented attempt at current standard of care but has not responded to treatment. The .gov means its official.Federal government websites often end in .gov or .mil. Any representation that creates an impression of official approval because of possession of an NDC number is misleading and constitutes misbranding. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at Screening (Visit 1) and a negative urine pregnancy test (UPT) prior to first dose. if (null === formElement) { See the drug establishment current registration site to check a facilitys current registration. Contact FDA Follow FDA on Facebook Follow FDA on Twitter View FDA videos on YouTube Subscribe to FDA RSS feeds. The product is in active clinical development. 1500 Capitol Ave, MS 7602. FDAs reorganization reflects the agencys commitment to modernizing its structure to advance its mission to protect and promote public health, and to meet the challenges of rapid innovation across the industries regulated by FDA. If you experience any issues accessing the data or issues related to data accuracy, please report your concerns via the CDER Contact form. We recognize that we must have a minimum level of evidence that the new medicine is likely to work before considering early access and must not provide excessive risk to any patients who may receive the new medicine early. Examples of questions for this point of contact: Contact spl@fda.hhs.gov for technical help and inquiries regarding XForms. (An alphabetical listing of staff is also available. At present, Vedanta has not established an expanded access program and does not offer expanded access to our investigational product candidates outside of a clinical trial. if (null !== formElement) { During Normal Business Hours (8 a.m. - 4:30 p.m. If you have questions about Venatorxs EA policy, please contact medinfo@venatorx.com. FdA: Employee Directory | ZoomInfo.com The patients physician and enrolling physician determine there is no comparable or satisfactory therapy available to treat the patients disease or condition and they agree that the patient is clinically stable and able to receive this medication. The National Drug Code (NDC) Directory is updated daily. Before sharing sensitive information, make sure you're on a federal government site. Additional regarding the therapy, its development program, the patient, or other circumstances may impact eligibility. } A lock (LockA locked padlock) or https:// means youve safely connected to the .gov website. We encourage patients who are interested in accessing therapies in our pipeline to talk to their doctor about participating in a clinical trial. Staff Listing (An alphabetical listing of staff is also available.) Show advanced filters Use the map above or select from this list of available states and territories: United States Alabama Alaska Arizona Arkansas Adequate supply of the investigational drug is available. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. III, San Fernando City, La Union(072)682-0708, b. Sexually active WOCBP and male patients must agree to use highly effective birth control or abstinence until 3 months after last dose. FDA Commssioner: 10: Sophia: Donaldson: GS-Career: Assoicate Deputy Chief Information Officer Center for Tobacco Products-- Not Provided - 10: Michael: Foecking: GS: formTimeDiff += cumulatedTime; The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the . History or presence of hypersensitivity or idiosyncratic reaction to voriconazole or excipients in Voriconazole Inhalation Powder. The patient has a disease for which there is sufficient evidence of a projected benefit from the use of the investigational product and the benefit outweighs the known or anticipated risks. Several important medical and logistic criteria need to be met including: The disease is serious or life-threatening; All other available alternative therapies have been exhausted, but the patient may still benefit from further treatment with an investigational medicines; A clinical trial is not available, either because patients are ineligible or because they have no access to the trial; The efficacy and safety data available at the time are of sufficient strength to determine whether the benefit to the patient would likely outweigh the potential risks; and. FDA Offices - Illinois (Food & Drug Safety) - County Office South Luzon ClusterFDA Building, Civic Drive, Filinvest Corporate City, Alabang, Muntinlupa City(02)8 857-1900 local 8106, a. ), Division of Education and Development (DED), Secretary's Advisory Committee on Human Research Protections (SACHRP). Sufficient scientific evidence to support both the safety and the efficacy of the compounds mechanism for this indication, A serious or life-threatening illness, with no other satisfactory treatment options (such as approved products or enrolling clinical trials), Sufficient evidence that the potential benefit to the patient would likely outweigh the potential risks, based on all available safety and efficacy information, Support that providing the investigational drug will not interfere with clinical trials that could support the investigational drugs development or regulatory approval for the treatment indication, which could affect future patient access. openFDA features harmonization on specific identifiers to make it easier to both search for and understand the drug products returned by API queries. We do this by running a thoughtfully designed and robust clinical trial program. How do I obtain an x.509 digital certificate? Learn more about CDRH's Quality Management Program. Pulmonary infections with voriconazole sensitive fungi other than Aspergillus such as but not limited to scedosporium and fusarium are also allowed. Office of the Commissioner | FDA - U.S. Food and Drug Administration The drug labeling and other information has been reformatted to make it easier to read but its content has neither been altered nor . Bureau IT Leadership Directory. Any use of a Xynomic investigational product outside a clinical study in a country must be in accordance with local laws and regulations governing such programs, including Xynomic policies and procedures. FdA Employee Directory . Are ineligible for participation in any ongoing clinical study of the investigational product, which includes lack of access due to geographic limitations. please report your concerns via the CDER Contact form . Whether the patient has a serious or life-threatening illness, Whether the patient has undergone standard treatment without success or there is no viable alternative therapy, Whether the potential benefits of the experimental product will outweigh any potential risk to the patient, Whether the patient is ineligible for or is unable to participate in a clinical trial for the investigational product, The impact of providing access to an investigational product on the development program for that product, The impact of providing access to an investigational product on the available inventory and supply for that product, The illness must be serious or life-threatening with no other satisfactory treatment options (such as approved products or open clinical trials), There is sufficient evidence that the potential benefit to the patient would likely outweigh the potential risks, based on available safety and efficacy information, The ability to provide a therapy in a fair and equitable manner, so that there is adequate manufacturing capacity to provide therapies across all ongoing clinical trials and expanded access programs, Whether granting expanded access would potentially compromise the scientific validity of broader development programs, or interfere with or delay current clinical trials or regulatory filings designed to make the therapy available to many more patients, There must be adequate supply of the investigational product to meet the needs of the expanded access program without impacting the companys clinical trials, There is a compelling medical and scientific rationale for the requested use, The potential benefit to the patient must outweigh the collective potential risks, There must be sufficient clinical data to identify an appropriate dose, The patients physician has determined that treating the patient with the investigational product is in the patients best interests. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. | Note: For HHS OIG personnel inquiries, please proceed to https://oig.hhs.gov/ At Viela Bio, we work every day to improve the lives of people impacted by serious, underserved, inflammatory and autoimmune diseases. Integrate applicable quality management and organizational excellence principles and best practices into key business processes. At this time, we are not yet providing Expanded Access. Whenever possible, the patient, the patients parent/legal guardian, or patient caregiver should work through the treating physician rather than contacting VelosBio directly. The medicine requested is part of an active ongoing clinical development program at Taiho Oncology (US) as described on our website: Provision of the investigational agent will not interfere with the ongoing Taiho development program, and the potential benefits to the patient outweigh the potential risks. Director, Center for Devices Has the Famous "HHS Directory" Suddenly Dropped Email for Staff? Following are points of contact for specific questions about registration and listing for human drugs, animal drugs and biologics. Contact CFSAN | FDA Please search ClinicalTrials.gov for publicly available information related to Venatorxs ongoing clinical trials. Deputy Chief Information Officer; Director, Portfolio Management & Governance Division, Deputy Assistant Secretary for Administration, Deputy Chief Information Officer (Acting); Director, Portfolio Management & Governance Division, Director, IT Policy, Strategy & Planning Division, Director, Solutions and Services Division, Supevisory Business Informatics Associate Deputy Chief Information Officer, Center for Food Safety and Applied Nutrition Director, National Center for Toxicological Research Director, Supervisor Business Process Improvement Specialist, Chief Information Officer Office of the Commissioner/Office of Digital Transformation, Assoicate Deputy Chief Information Officer, Center for Biologics Evaluation and Research Director, Associate Deputy Chief Information Officer, Chief Data Officer Office of the Commissioner/ Office of Digital Transformation/ Office of Data, Analytics, and Research, Director Office of Technology and Development, Director Office of Business and Customer Assurance, Center for Drug Evaluation and Research Director, Assocuiate Director, Digital Transformation, Center for Devices and Radiological Health Director, Associate Deputy Chief Information Officer Director Office of Enterprise Portfolio Management, Director, Office of Information System Management, Chief Artificial Intelligence Officer (CAIO), Executive Director, Office of Application & Platform Solutions (OAPS), Executive Director, Office of Enterprise Services (OES), Acting Executive Director, Office of Operations (OPS), Chief Information Security Officer (CISO), IHS Deputy Chief Information Officer / Alternate, Office of Information Technology Director, Division Director of Information Technology, Division Director of Program Management and Budget, Division Director of Information Technology Operations, Division Director of Health IT Management and Operations, Division Director of Data Management and Analytics, CIO/Director, National Institutes of Health (Acting), Deputy CIO, National Institutes of Health (Acting), Director, Center for Information Technology (Acting), Chief Information Officer (Acting) and Chief Technology Officer, Deputy Inspector General for Management and Policy, Division of Technology Management and CIO, Director, Office of Management, Technology and Operations (OMTO), Deputy Assistant Secretart for Office of Administration (Acting) Chief Information Officer, Director, Office of Information Technology | Deputy Chief Information Officer, Division Director, IT Oversight & Governance. Association of Food and Drug Officials Many perspectives, one voice, since 1896. The patient has a serious or life-threatening illness or condition and is either no longer responsive to or no longer able to tolerate any available treatment option. Food and Drug Administration | USAGov Inclusion of information in the NDC Directory does not indicate that FDA has verified the information provided. Before sharing sensitive information, make sure you're on a federal government site. To read more about Drug NDC Directory, please visit: Do not rely on openFDA to make decisions regarding medical care. Patient succeeds in meeting training criteria on the use of the dry powder inhaler (DPI) and is willing and able to perform adequate inhalation technique for treatment duration in the opinion of the treating clinician or designee. An official website of the United States government. How long does it take to open a new gateway account? This service is provided by the USDA-Office Information Profile System. Provide leadership and direction for Center-level management, planning, and evaluation systems to ensure optimal utilization of personnel, budgetary and financial resources. The openFDA drug NDC Directory endpoint returns data from the NDC Directory, a database that contains information on the National Drug Code (NDC). Regional Field Office X2nd Floor, Almie Rose Chan Yu Bldg., Zone 7, Bulua, Cagayan de Oro City(088) 882-2842, b. Under certain circumstances, a person suffering a serious or life-threatening disease may ask to use an experimental treatment outside a clinical trial, before its safety and efficacy have been fully evaluated, and before the regulatory authorities have approved it. : Agency: Other org..: Job title..: Return no more than rows (maximum 500). How do I send product labels in my XForms submission? The Association of Food and Drug Officials (AFDO) is a regulatory organization that connects food and medical-products safety stakeholders and impacts the regulatory environment by shaping sound, science-based rules, law, regulations, and sharing best practices that protect public health. Contact FDA; . ORA Program Division Directors | FDA - U.S. Food and Drug Administration Any requirements from Lion TCR in terms of medical criteria, safety reporting, drug supply/use and protection of intellectual property. Office: 615-366-7803, An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, Commonwealth of the Northern Mariana Islands. Points of Contact for Drug Registration and Listing | FDA Food and Drug Branch - California Department of Public Health The content of each NDC Directory entry is the responsibility of the labeler submitting the SPL file. The .gov means its official.Federal government websites often end in .gov or .mil. A benefit-risk analysis, based on both the available clinical data as well as the requesting physicians assessment of the individual patients condition and history, supports making the investigational drug available. All patient information must be redacted so that no personally identifiable information is transmitted. Once our clinical trials have progressed to Phase 3 and we are able to provide Expanded Access, to be eligible for access to one of our investigational therapies via an Expanded Access mechanism, a physician must certify that the patient for whom the request is being submitted meets the following criteria*: The site is secure. Civic Drive Filinvest Corporate CityAlabang, Muntinlupa City This organization chart reflects the new structure. Xynomic is committed to making investigational products available to seriously ill patients who have exhausted other treatment options. Transthyretin-mediated Amyloidosis With Cardiomyopathy, Other Solid Tumors With Evidence of Activating RET Alteration, Adenocarcinoma of the Gastroesophageal Junction, Expanded Access Protocol to Provide Patisiran to Patients With Transthyretin-mediated Amyloidosis With Cardiomyopathy, Expanded Access for ATB200/AT2221 for the Treatment of IOPD, https://www.fda.gov/downloads/newsevents/publichealthfocus/expandedaccesscompassionateuse/ucm504494, https://www.asctherapeutics.com/expanded-access-policy/. An official website of the United States government, : For human drugs, contact edrls@fda.hhs.gov Quebec | Expanded Access Navigator - Reagan-Udall For emergency requests for all medical products (drugs, biologics, and medical devices) contact FDA's Emergency Call Center at866-300-4374. A benefit-risk analysis, based on both the available clinical data as well as the requesting physicians assessment of the individual patients condition and history, supports making the investigational drug available; Making the investigational drug available will not negatively impact or delay the conduct of clinical trials or regulatory review or approval of the investigational drug for broader patient access; and, If you are not eligible for a clinical trial or no appropriate clinical trial exists, and your qualified treating physician believes that an investigational medicine available may be the best and the only treatment option for you, your physician should contact us on your behalf by emailing. Expanded Access Carpenter Hill, Koronadal City, South Cotabato (083)877-8803, Featured Activity || Official Statement of the FDA Director General, Featured Activity || Food and Drug Administration, Naaprubahan na ang, FDA Advisory No.2023-1501 || Public Health Warning Against the Purchase, NP-LRP-V-2023-0113-CFRR Accommodation, venue and meals for the live-in Preparatory. The patient does not have an option to participate in a relevant Ascendis sponsored clinical trial because of non-eligibility or the trial is not conducted in the patient's region. jsTimeInput.setAttribute("name", "tfa_dbElapsedJsTime"); Assignment of an NDC number does not in any way denote FDA approval of the product. Deputy Associate General Counsel (Foods & Veterinary Medicine), Peter Beckerman. Review the chart below to better understand which fields are harmonized. San Isidro, City of San Fernando, Pampanga(045)649-4341, a. HHS Organizational Directory Browse Organizations | Search employees | Customize To make corrections, see the HHS directory contact list. Main Telephone: (800) 495-3232. FDA's Expanded Access Contact Information | FDA Provision of the investigational therapy will not interfere with the ongoing development program, and the potential benefits to the patient outweigh the potential risks We are currently unable to offer expanded access for varoglutamstat (PQ912) and we believe that participation in one of our clinical trials is the most appropriate way to access our investigational therapies.More Information The drug labels and other drug-specific information on this Web site represent the most recent drug listing information companies have submitted to the Food and Drug Administration (FDA). if (null !== formElement) { First name. A clearly documented biological or clinical rationale should support the potential clinical benefit to the patient. There is an adequate supply of the investigational medicine in local. Contact edrls@fda.hhs.gov for questions and assistance with registration. Requests require both HCP to initiate the request as well as signed consent by the patient. let appendJsTimerElement = function(){ jsTimeInput.setAttribute("value", formTimeDiff.toString()); The patient has a serious or life-threatening illness or condition and is either no longer responsive to or no longer able to tolerate any available treatment option; The investigational drug is in active clinical development, with the clinical development having reached the stage of blinded Phase 3 data read-out. Please call or e-mail before faxing documents. Patient provides informed consent and agrees to follow the treatment regimen and safety and outcomes assessments. For general questions about medical devices regulation, contact the Division of Industry and Consumer Education at dice@fda.hhs.gov or 800.638.2041 or 301.796.7100. openFDA annotates the original records with, NDC Directory data definitions and download page. Vivoryon will acknowledge questions as soon as possible, usually within 5 business days of receipt.

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