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.
22820 articles with Food and Drug Administration (FDA)
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Jasper Therapeutics Announces Orphan Drug and Rare Pediatric Disease Designations for JSP191 for Conditioning Treatment Prior to Stem Cell Transplant
6/14/2021
Jasper Therapeutics, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to JSP191, a monoclonal antibody targeting the CD117 (stem cell factor) receptor.
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Humanigen Initiates Submission for Lenzilumab Marketing Authorization in COVID-19, to the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA)
6/14/2021
Humanigen, Inc., a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’, announced it has initiated a rolling review submission for Marketing Authorization by the MHRA for its lead drug candidate, lenzilumab.
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Istari Oncology Announces FDA Granted Fast Track Designation to PVSRIPO for the Treatment of Advanced Melanoma
6/14/2021
Istari Oncology, Inc. announced today the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to PVSRIPO for the improved survival in patients with advanced melanoma.
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Landos Biopharma Announces Positive Outcome of End-of-Phase 2 Meeting with the FDA for Omilancor in Mild-to-Moderate Active Ulcerative Colitis (UC) Patients
6/14/2021
Landos Biopharma, Inc. announced the successful outcome of an End-of-Phase 2 meeting with the U.S. Food and Drug Administration for omilancor, its lead candidate in late-stage clinical development for the treatment of mild-to-moderate active ulcerative colitis patients.
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The FDA stated that the unpredictable and delayed analgesia onset with the intravenous therapy could not support a benefit when given alone to manage acute pain.
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The month of June continues to be busy for the U.S. Food and Drug Administration. There are three PDUFA dates on the calendar for this week. Here’s a look.
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The EMA identified a rare blood condition, capillary leak syndrome, as a potential side effect of AstraZeneca’s Vaxzevria.
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Enochian BioSciences Announces FDA Acceptance of Pre-IND Request For Potential HIV Cure
6/14/2021
Enochian BioSciences, Inc., a company focused on gene-modified cellular and immune therapies in infectious diseases and cancer, announced that the FDA has accepted a Pre-IND request for a potential functional cure or treatment of HIV.
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The FDA accepted its pre-Investigational New Drug request for a cell therapy treatment that could be a key factor in controlling HIV.
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Avenue Therapeutics Receives Complete Response Letter from the FDA for IV Tramadol
6/14/2021
Avenue Therapeutics, Inc., a company focused on the development of intravenous tramadol for the U.S. market, announced that it has received a second Complete Response Letter from the U.S. Food and Drug Administration regarding its New Drug Application seeking approval for IV tramadol.
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Molecular Partners Announces First Patient Dosed in COVID-19 NIH-Sponsored ACTIV-3 Trial Evaluating Antiviral Candidate Ensovibep
6/13/2021
Molecular Partners AG announced that the first patient has been dosed in a new Phase 3 sub-study evaluating ensovibep, as part of the National Institutes of Health's Accelerating COVID-19 Therapeutic Interventions and Vaccines public-private partnership designed to speed development of treatments and vaccine candidates for COVID-19.
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Alzheimer's Association Statement: Next Steps For New Alzheimer's Treatment
6/12/2021
As the global nonprofit leader in Alzheimer's research and science we have extensively reviewed the clinical trial data for Aduhelm™.
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Vicore announces FDA acceptance for pivotal phase 3 trial of C21 in COVID-19
6/11/2021
Vicore Pharma Holding AB announces that the U.S. Food and Drug Administration has accepted the Investigational New Drug application for the company's lead asset, the orally available angiotensin II type 2 receptor agonist C21, for the treatment of COVID-19.
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Quidel Receives Amended Emergency Use Authorization for New Sofia® Q Rapid Antigen Test Device
6/11/2021
Quidel Receives Amended Emergency Use Authorization for New Sofia ® Q Rapid Antigen Test Device
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Aaron Kesselheim, a professor of Medicine at Harvard Medical School and has served on the advisory committee since 2015, has stepped down.
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Beigene presented results from three pivotal trials at the 26th EHA2021 Virtual Congress for the effectiveness of their checkpoint inhibitor tislelizumab in relapsed or refractory lymphoma.
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Nuvo Group Receives 510(k) FDA Clearance for Remote Monitoring of Uterine Activity
6/10/2021
New clearance expands clinical utility of INVU by Nuvo™ platform to include monitoring of fetal heart rates, maternal heart rates and uterine activity, allowing nonstress tests to be performed remotely.
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Cardinal Health™ Nuclear & Precision Health Solutions Receives U.S. Food and Drug Administration Approval for New LYMPHOSEEK® Pediatric Indication
6/10/2021
Cardinal Health (NYSE: CAH) today announced that LYMPHOSEEK ® has been approved for pediatric use by the U.S. Food and Drug Administration (FDA).
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Neurescue's Breakthrough Intelligent Balloon Catheter FDA 510(k) Cleared for Hemorrhage Control and IDE Approved for Cardiac Arrest
6/10/2021
Device is FDA IDE approved to start a clinical study in the U.S. to investigate a novel cardiac arrest treatment indication.
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Medtronic Announces FDA Approval of its Next Generation Recharge-Free Spinal Cord Stimulation Platform
6/10/2021
Medtronic plc (NYSE: MDT) today announced it has received U.S. Food and Drug Administration (FDA) approval for Vanta™, a high performance recharge-free implantable neurostimulator device life that can be optimized up to 11 years.