Food and Drug Administration (FDA)
5600 Fishers Lane
Rockville
Maryland
20857
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.
19284 articles with Food and Drug Administration (FDA)
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ViewRay Announces FDA 510(k) Clearance for Advancements in MRI and Functional Imaging Technologies for MRIdian MRI-Guided Radiation Therapy System
2/21/2019
Proprietary Technology from ViewRay Enables Imaging and Treatment Enhancements
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Xencor Announces Partial Clinical Hold on Phase 1 Study of XmAb14045
2/20/2019
Xencor, Inc. announced that the U.S. Food and Drug Administration has placed a partial clinical hold on its Phase 1 study of XmAb14045, a CD123 x CD3 bispecific antibody molecule being evaluated in patients with relapsed or refractory acute myeloid leukemia and other CD123-expressing hematologic malignancies.
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FDA Grants Priority Review to Merck’s Supplemental Biologics License Application for KEYTRUDA® (pembrolizumab) Monotherapy for Third-Line Treatment of Patients with Advanced Small Cell Lung Cancer (SCLC)
2/20/2019
Merck announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for a new supplemental Biologics License Application (sBLA) for KEYTRUDA
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Melanoma Research Alliance Welcomes FDA Approval of Pembrolizumab in Adjuvant Setting
2/20/2019
The Melanoma Research Alliance, the largest non-profit funder of melanoma research worldwide, applauds the U.S. Food & Drug Administration approval of Merck’s pembrolizumab in the adjuvant setting for melanoma patients with lymph node involvement following complete lymph node resection.
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MagVenture, Inc.: Robotic Aid to Drugfree Depression Treatment Receives FDA Clearance
2/20/2019
MagVenture, a medical device company providing drugfree depression treatment to the US since 2015, has added a new, FDA cleared robotic platform to their clinical system.
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Hygieia Receives 510(k) Clearance from FDA for Phone App That Enhances Company's d-Nav Insulin Guidance Service
2/20/2019
First Insulin-Management App Able to Titrate All Types of Insulin Regimens for People with Type 2 Diabetes and Connect To Any Glucose Meter That Shares Data with the Cloud
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The study found that the majority of patients who were given the powerful painkiller did not have cancer or pain associated with the disease, which is what the drug is indicated to help.
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On Tuesday, Novo Nordisk said the FDA approved its Biologics License Application for Esperoct (turoctocog alfa pegol) formerly known as N8-GP, for the treatment of children and adults with hemophilia A.
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Keytruda failed to show a statistical significance in overall survival and progression free survival in the Phase III trial.
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The patients were part of a trial assessing Xencor's mAb14045, a CD123 x CD3 bispecific antibody molecule being evaluated in patients with relapsed or refractory acute myeloid leukemia.
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In the seventeenth century, Hungarian Countess Elizabeth Bathory bathed in the blood of young women she murdered in order to sustain her beauty. Blood, albeit more freely given, continues to be an attractive tool for some who want to stave off the effects of age.
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FDA Approves Merck’s KEYTRUDA® (pembrolizumab) for the Adjuvant Treatment of Patients with Melanoma with Involvement of Lymph Node(s) Following Complete Resection
2/19/2019
U.S. Approval Based on Significant Recurrence-Free Survival (RFS) Benefit Demonstrated with KEYTRUDA in Phase 3 EORTC1325/KEYNOTE-054 Trial
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New Drug Landscape Dominated by High-cost Medicines
2/19/2019
The Patented Medicine Prices Review Board published the 2017 edition of Meds Entry Watch, an annual publication that provides the latest information on new medicines entering Canadian and international markets.
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Biohaven's Verdiperstat Receives Orphan Drug Designation From FDA For Multiple System Atrophy
2/19/2019
Biohaven Pharmaceutical Holding Company Ltd. announced that it received orphan drug designation from the U.S. Food and Drug Administration for its product candidate verdiperstat, a novel myeloperoxidase inhibitor, for the treatment of multiple system atrophy.
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AbbVie Announces New Drug Application Accepted for Priority Review by U.S. FDA for Upadacitinib for Treatment of Moderate to Severe Rheumatoid Arthritis
2/19/2019
Upadacitinib, an investigational once-daily oral JAK1-selective inhibitor, is being studied for the treatment of adult patients with moderate to severe rheumatoid arthritis
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Medtronic Receives FDA Breakthrough Designation for Developing Personalized Closed Loop Insulin Pump System for Diabetes Management
2/19/2019
Medtronic plc, the global leader in medical technology, announced it has received Breakthrough Device designation from the U.S. Food and Drug Administration for its Personalized Closed Loop insulin pump system, currently in development.
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Xellia Pharmaceuticals Receives US FDA Approval for Premixed Vancomycin Injection
2/19/2019
Xellia Pharmaceuticals announced it has received U.S. Food and Drug Administration (FDA) approval for Premixed Vancomycin Injection in a Ready-to-Use (RTU) bag in the United States market.
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ReWalk Announces 510k FDA Submission for ReStore™ Exo-Suit for Stroke Rehabilitation
2/19/2019
Innovation in robotic rehabilitation technology will provide the first-of-its-kind medical device to rehab clinics nationwide, to treat the millions of patients with lower limb disability due to stroke
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FDA Grants Priority Review to Genentech’s Polatuzumab Vedotin in Previously Treated Aggressive Lymphoma
2/19/2019
Feb. 19, 2019 06:00 UTC FDA Grants Priority Review to Genentech’s Polatuzumab Vedotin in Previously Treated Aggressive Lymphoma -- Diffuse large B-cell lymphoma is an aggressive type of blood cancer that typically becomes harder to treat each time it returns -- -- Polatuzumab vedotin has shown significant potential to improve outcomes in people living with this disease -- SOUTH SAN FRANCISCO, Calif.-
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FDA Grants Priority Review to Genentech’s Personalized Medicine Entrectinib
2/19/2019
Genentech announced that the U.S. Food and Drug Administration has accepted the company’s New Drug Applications and granted Priority Review for entrectinib