Today we approved the first biosimilar to treat certain rare diseases. https://t.co/MOFBRo3s5E This biosimilar is approved to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis; and patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy.
About us
The Food and Drug Administration is an agency within the Department of Health and Human Services. 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 safety of our nation's food supply, cosmetics, and products that emit radiation. FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. FDA is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health. FDA also plays a significant role in the Nation's counterterrorism capability. FDA fulfills this responsibility by ensuring the security of the food supply and by fostering development of medical products to respond to deliberate and naturally emerging public health threats.
- Website
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http://www.fda.gov/
External link for FDA
- Industry
- Government Administration
- Company size
- 10,001+ employees
- Headquarters
- Silver Spring, MD
- Type
- Government Agency
- Specialties
- Food, Drugs, Medical Devices, Vaccines Blood and Biologics, Animal and Veterinary, Cosmetics, Radiation-Emitting Products, Tobacco Products, Regulatory Research, and Toxicological Regulatory Research
Locations
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Primary
10903 New Hampshire Ave
Silver Spring, MD 20993, US
Employees at FDA
Updates
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Today, FDA issued a draft guidance that outlines how a well-understood and reproducible technology in an FDA-approved drug or biological product may be eligible for a platform technology designation: https://lnkd.in/egqRQuiv
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#CBEROTP is accepting public comments on a draft guidance regarding “Considerations for the Use of Human-and Animal-Derived Materials in the Manufacture of Cell and Gene Therapy and Tissue-Engineered Medical Products.” Submit comments by July 29, 2024. https://bit.ly/49TKblq
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On June 26-27, 2024, we will co-sponsor a public workshop to illustrate how patient-generated health data (PGHD) can promote medical device innovation throughout the total product life cycle. Join us to hear patients, industry sponsors, regulators, and researchers share their perspectives on how using PGHD can help advance remote clinical trial data collection and support clinical outcome assessments. The deadline to register is June 25, 2024. Learn more about the virtual event: https://lnkd.in/e_vjqdeH
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Check out the state of immunotherapy in resectable non-small cell lung cancer (NSCLC): This American Society of Clinical Oncology (ASCO) Educational Book article (free access) includes views from academia and the FDA. Good warmup for #ASCO24 Education Session “Integrating Immunotherapy into Early-Stage Lung Cancer" on June 2. https://lnkd.in/eRiS3Vnx FDA's Dr. Bernardo Haddock Lobo Goulart will present and serve as a panelist in this discussion. → Ongoing trials of immunotherapy and RT for early stage NSCLC. → Clinical implications of recent advances in immunotherapy for resectable NSCLC. → Current trial designs assessing immunotherapy in resectable NSCLC: challenges, opportunities. #LungCancer #Immunotherapy
Moving Immunotherapy Into the Treatment of Resectable Non–Small Cell Lung Cancer
ascopubs.org
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Don’t miss out! The 2024 Regulatory Education for Industry (REdI) Conference kicks-off tomorrow (May 29-30). The conference will be recorded on YouTube Live, and all registered attendees will be able to view at the end of each day. https://lnkd.in/gV5PvVmy #MedicalDevice #FDA
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FDA's Oncology Center of Excellence invites you to the next #ConversationsOnCancer on June 13, at the start of National Black Family Cancer Awareness Week. This year's theme, “Engaging the Generations,” is a powerful call to action against cancer. OCE's Project Community began this initiative in 2021, during the 50th anniversary of the National Cancer Act and the signing of Presidential Executive Order 13985, focusing on equity and inclusion in cancer research. The initiative seeks to mobilize community-based stakeholders to build knowledge surrounding cancer clinical trial participation and minority population specimen donations to national genomic databases for cancer research. Join us in this critical conversation and help us spread the word. Together, we can make a difference in the fight against cancer. Register to be a part: https://lnkd.in/e8wEPV57 #BlackFamCan #OCEProjectCommunity #CancerAwareness #EngagingTheGenerations #ClinicalTrials #CancerResearch
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Today, FDA published the FY 2023 Generic Drug User Fee Amendments (GDUFA) Science and Research Report summarizing the scientific progress and research outcomes that support the development and assessment of generic drugs: https://lnkd.in/efVXP2aa GDUFA research provided the scientific foundation for the approval of complex generic drugs, such as medicines used to treat patients with alcohol use disorder and opioid dependence. GDUFA research helps FDA establish new approaches for manufacturers to develop generic drugs that were previously too challenging to develop, which helps make more generic medicines available. Read the report for more information.
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Do you currently treat patients with opioid use disorder? ✔ Yes, and it has been successful! ✔ Yes, but only a few patients. ✔ No, I am too busy and not sure where to start. ✔ I am passionate about treating patients with opioid use disorder but am not a prescriber. FDA is launching a new campaign that aims to help primary care providers recognize and treat opioid use disorder (OUD). Visit our website to find free training, firsthand testimonials, and other resources to help providers get started: https://lnkd.in/d-W9FV-F. Prescribe with Confidence: Patients with Opioid Use Disorder Need You. Drop your success stories, your challenges, and your inspiration in the comments. #Prescribewithconfidence