Food and Drug Administration (FDA)
5600 Fishers Lane
Rockville
Maryland
20857
United States
Tel: 888-463-6332 or 1-888-INFO-FDA (1-888-463-6332)
Website: http://www.fda.gov/
About Food and Drug Administration (FDA)
FDA Overview:
The Food and Drug Administration is one of the nation's oldest and most respected consumer protection agencies. This presentation will tell you about FDA's responsibilities, the tools we use to fulfill those responsibilities, and our priorities for improving the way we serve the public.
•Stated most simply, FDA's mission is:
- to promote and protect the public health by helping safe and effective products reach the market in a timely way,
- To monitor products for continued safety after they are in use, and
- To help the public get the accurate, science-based information needed to improve health.
FDA's Mission Statement
The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.
26404 articles about Food and Drug Administration (FDA)
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Scopio Labs Receives Groundbreaking FDA Clearance for First-Ever Digital Bone Marrow Aspirate Application
4/17/2024
Scopio Labs today announced that it has been granted De Novo clearance by the U.S. Food and Drug Administration (FDA) for its Full-Field Bone Marrow Aspirate™ (FF-BMA) Application.
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FDA Roundup: April 16, 2024
4/16/2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
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Lupus Accelerating Breakthroughs Consortium Announces Expanded Partnership with U.S. FDA at First Anniversary Meeting
4/16/2024
The Lupus Research Alliance (LRA), founder and administrator of the Lupus Accelerating Breakthroughs Consortium (Lupus ABC), announced today at the Consortium's first anniversary meeting an expanded partnership with the U.S. Food and Drug Administration (FDA) with the inclusion of the Center for Biologics Evaluation and Research (CBER).
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Xstim, Inc. Receives FDA Approval for Xstim™ Spine Fusion Stimulator.
4/16/2024
Xstim, Inc., a pioneering developer and manufacturer of cutting-edge bone growth stimulation systems, is thrilled to announce its recent Premarket Application approval from the U.S. Food and Drug Administration for Xstim™ Spine Fusion Stimulator.
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Novartis’ Intravenous Formulation of Cosentyx Impacting Prescriber Preferences in Psoriatic Arthritis Treatment, While Pending Launch of UCB’s Bimzelx Poised to Further Disrupt the Market
4/16/2024
In October of 2023, the US FDA approved Novartis’ intravenous formulation of Cosentyx for the treatment of psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis.
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Lexeo Therapeutics Granted FDA Fast Track Designation for LX2006, an AAV-Based Gene Therapy Candidate for the Treatment of Friedreich’s Ataxia Cardiomyopathy
4/16/2024
Lexeo Therapeutics, Inc. today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to LX2006, the company’s AAVrh.10hFXN-based gene therapy candidate for the treatment of Friedreich’s ataxia (FA) cardiomyopathy.
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Alvotech and Teva Announce U.S. FDA Approval of SELARSDI™ (ustekinumab-aekn), biosimilar to Stelara® (ustekinumab)
4/16/2024
Alvotech and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd., announced that the U.S. Food and Drug Administration has approved SELARSDI injection for subcutaneous use, as a biosimilar to Stelara®, for the treatment of moderate to severe plaque psoriasis and for active psoriatic arthritis in adults and pediatric patients 6 years and older.
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Fresenius Accelerates Momentum in its (Bio)Pharma Business and Launches Tyenne®, its Third Approved Biosimilar in the U.S.
4/15/2024
Fresenius, via its operating company Fresenius Kabi, announced the immediate U.S. availability of Tyenne®, a biosimilar of Actemra®.
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FDA Grants Soligenix Orphan Drug Designation for the Prevention and Post-Exposure Prophylaxis Against Marburg Marburgvirus Infection
4/15/2024
Soligenix, Inc. announced today that the Office of Orphan Products Development of the United States (U.S.) Food and Drug Administration (FDA) has granted orphan drug designation to the active ingredient in MarVax™, the subunit protein vaccine of recombinantly expressed Marburg marburgvirus (MARV) glycoprotein, for "the prevention and post-exposure prophylaxis against MARV infection."
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TLX101-CDx (Pixclara™) Granted FDA Fast Track Designation
4/15/2024
Telix Pharmaceuticals Limited announces that the United States Food and Drug Administration has granted Fast Track designation for the Company’s investigational glioma imaging product, TLX101-CDx.
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FDA Roundup: April 12, 2024
4/12/2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
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PureTech Receives FDA Fast Track Designation for LYT-200 in Head and Neck Cancers
4/11/2024
PureTech Health plc announced that the U.S. Food and Drug Administration has granted Fast Track designation for LYT-200 in combination with anti-PD1 therapy for the treatment of recurrent/metastatic head and neck squamous cell carcinomas.
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FASENRA approved for treatment of children aged 6 to 11 with severe asthma
4/11/2024
AstraZeneca’s FASENRA® is now approved by the US Food and Drug Administration for add-on maintenance treatment for patients with severe asthma aged 6 to 11 with an eosinophilic phenotype.
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Candel Therapeutics Receives FDA Orphan Drug Designation for CAN-2409 for the Treatment of Pancreatic Cancer
4/11/2024
Candel Therapeutics, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to CAN-2409, Candel’s most advanced multimodal biological immunotherapy candidate, for the treatment of pancreatic cancer.
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Labcorp Receives FDA Emergency Use Authorization for Mpox PCR Test Home Collection Kit
4/10/2024
Labcorp announced the U.S. Food and Drug Administration has granted Emergency Use Authorization for its Mpox PCR Test Home Collection Kit to aid in the diagnosis of infection with non-variola Orthopoxvirus, including the monkeypox virus that causes monkeypox, also known as mpox.
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Roche obtains CE Mark for first companion diagnostic to identify patients with HER2-low metastatic breast cancer eligible for ENHERTU
4/10/2024
Roche announced the approval of the CE Mark for the VENTANA® HER2 Rabbit Monoclonal Primary Antibody RxDx* to identify metastatic breast cancer patients with low HER2 expression for whom ENHERTU® may be considered as a targeted treatment.
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16 Bit Announces FDA De Novo Marketing Authorization of Rho, an AI-enabled Opportunistic Pre-Screen for Low Bone Mineral Density on Standard X-Rays
4/10/2024
16 Bit Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted a De Novo marketing authorization for Rho™, an AI-enabled software device aimed at improving a known care gap in osteoporosis screening.
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HOOKIPA Pharma to Host Investor Call on HB-200 and Planned Path to Registration
4/10/2024
HOOKIPA Pharma Inc. announced that members of HOOKIPA’s Executive Team will host an investor call summarizing the Company’s constructive regulatory interactions with the U.S. Food & Drug Administration and the European Medicines Agency.
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AdrenoMed Receives FDA Fast Track Designation for Enibarcimab for Treatment of Septic Shock
4/10/2024
AdrenoMed AG, the vascular integrity company, today announced that the US Food and Drug Administration (FDA) has granted Fast Track designation to its lead product candidate enibarcimab, a first-in-class non-neutralizing monoclonal antibody, for the treatment of septic shock.
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Syros Receives Fast Track Designation from the FDA for Tamibarotene for the Treatment of Newly Diagnosed Unfit AML with RARA gene overexpression
4/9/2024
Syros Receives Fast Track Designation from the FDA for Tamibarotene for the Treatment of Newly Diagnosed Unfit AML with RARA gene overexpression.