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.
18902 articles with Food and Drug Administration (FDA)
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Multiple biotech companies are scheduled to release their quarterly reports next week. BioSpace takes a quick look at some these companies and the announcements they have made through 3Q2018.
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Part of the Trump Administration and the U.S. Food and Drug Administration (FDA)’s strategy to push down drug prices is to develop ways to increase competition. As such, the agency launched a Drug Competition Action Plan that has several components.
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Shares of Clovis Oncology are up more than 7 percent in premarket trading after the company announced positive results from a mid-stage clinical trial that showed patients treated with Rubraca achieved a 44 percent objective response rate in some patients with metastatic castration resistant pros...
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19 (at Least!) of TIME Magazine’s 50 Most Influential Healthcare People Have Biopharma Ties
10/19/2018
TIME Magazine came out with a list of the 50 most influential people in healthcare, dubbed The Health Care 50. A look through the list shows just how many ties and connections—as well as influence—this group has on the biopharma industry. -
VISEON, Inc. Announces FDA Clearance of the Voyant System for Minimally Invasive Spine Surgery Access, Visualization, and Illumination
10/18/2018
Viseon, Inc. today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for their Voyant System for Minimally Invasive Spine Surgery, featuring proprietary HD imaging sensor and illumination technology.
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Every year, the Breakthrough Prize Foundation awards a collective total of $22 million to nine researchers for achievements in the Life Sciences, Fundamental Physics and Mathematics.
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Shares of Indiana-based Endocyte have shot up more than 50 percent in pre-market trading after Swiss pharma giant Novartis announced it was acquiring the company for $2.1 billion in cash. The deal will allow the company to expand its radiopharmaceuticals business.
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Immune Design Abandons Cancer Vaccine Program, Drops 20% of Workforce at Two U.S. Locations
10/18/2018
The company, with sites in Seattle and South San Francisco, focuses on next-generation oncology therapeutics. It recently completed a portfolio review and decided to focus its energies and existing capital on G100 and abandoned its CMB305 program. -
Bone-on-bone knee pain from osteoarthritis can be agonizing and often results in surgery. But for some patients, there is another therapy option gaining ground – engineered cartilage implants.
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Amidst Strong Quarterly Growth, Novartis Receives FDA Complete Response Letter for Canakinumab
10/18/2018
Buried deep in an announcement touting a 6 percent growth in net sales driven by strong revenue gains of Cosentyx, Swiss pharma giant Novartis reported it received a Complete Response Letter from the U.S. Food and Drug Administration for canakinumab as a potential treatment for cardiovascular ris... -
Overall, the Swiss-based Roche announced a group sales increase of 7 percent, with the Pharmaceuticals Division up 7 percent, largely driven by sales of Ocrevus, Perjeta, Alecensa and Tecentriq.
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Recently, 23andMe partnered with GlaxoSmithKline, causing the Forbes Technology Council to cite eight ways these types of partnerships will affect disease treatments. These types of partnerships aren’t exactly new.
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Shares of Regeneron jumped more than 5 percent Monday after the company announced that its blockbuster drug Dupixent (dupilumab) hit the mark in two Phase III trials studying the drug as a treatment for adults with inadequately-controlled chronic rhinosinusitis with nasal polyps.
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The U.S. FDA approved Pfizer’s PARP inhibitor, Talzenna (talazoparib), for patients with a germline BRCA-mutated (gBRCAm), HER2-negative breast cancer. The agency also approved Myriad Genetics’ diagnostic assay to identify the mutation.
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With a new wave of migraine medications now on the market from multiple drugmakers that block the calcitonin gene-related peptide receptor (CGRP-R), Express Scripts has chosen to back two medications and exclude a third from the list of drugs it will carry.
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CStone Receives U.S. IND Approval for PD-L1 Antibody CS1001
10/16/2018
CStone Pharmaceuticals today announced the recent approval of investigational new drug (IND) application from the United States Food and Drug Administration (FDA) for CS1001, a fully human anti-programmed death ligand 1 (PD-L1) monoclonal antibody independently developed by CStone.
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U.S. FDA Grants LYNPARZA® (olaparib) Orphan Drug Designation for Pancreatic Cancer
10/16/2018
Fourth Orphan Drug Designation in the U.S. for AstraZeneca and Merck’s LYNPARZA
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Cellenkos, Inc. Announces FDA Clearance of Investigational New Drug Application for CK0801 for Treatment-Resistant Guillain-Barré Syndrome
10/16/2018
Phase I trial of single agent CK0801 for patients with Guillain-Barré Syndrome who have relapsed after intravenous immunoglobulin (IVIG) and/or plasmapheresis (PE) therapy to commerce
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FDA and DHS increase coordination of responses to medical device cybersecurity threats under new partnership; a part of the two agencies' broader effort to protect patient safety
10/16/2018
As part of the Administration's ongoing efforts to strengthen cybersecurity in health care, the U.S. Food and Drug Administration and the U.S. Department of Homeland Security (DHS) announced a memorandum of agreement to implement a new framework for greater coordination and cooperation between the two agencies for addressing cybersecurity in medical devices.
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New data from an ongoing late-stage study reinforced the safety and efficacy of Cosentyx (secukinumab) as a beneficial treatment for patients with psoriatic arthritis and ankylosing spondylitis.