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.
18591 articles with Food and Drug Administration (FDA)
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FDA Grants Orphan Drug Designation to Onspira Therapeutics' Investigational Interleukin-1 Receptor Antagonist for the Treatment of Bronchiolitis Obliterans
8/14/2018
Onspira Therapeutics, announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to its investigational product, OSP-101
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Procleix® Zika Virus Assay Approved by the FDA for Blood Screening on the Procleix® Panther® System
8/14/2018
Procleix Zika Virus assay approved for the detection of viral RNA in plasma and serum specimens, previously used since June 2016 under IND protocol.
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Motif Bio Announces FDA Acceptance of New Drug Application with Priority Review for Iclaprim for Treatment of Acute Bacterial Skin and Skin Structure Infections
8/14/2018
Motif Bio plc (AIM/NASDAQ: MTFB), a clinical-stage biopharmaceutical company specialising in developing novel antibiotics, today announced that the U.S. Food & Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for iclaprim, a targeted, Gram-positive investigational antibiotic, for the treatment of acute bacterial skin and skin structure infections (ABSSSI).
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Acorda Therapeutics Chief Technology Officer Rick Batycky is leaving the company to take over the helm of an unnamed biotechnology company.
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Massachusetts in general and Boston, specifically Cambridge, is one of the two largest centers in the U.S. for biotech startups and life science companies (the other being the San Francisco Bay Area). Here’s a look at 13 Massachusetts life science companies that are showing both gains and losses—...
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7D Surgical Receives FDA Approval For Cranial Surgery
8/13/2018
7D Surgical announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration for its Cranial Module.
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Medicure Announces FDA Approval of Acute Care Cardiovascular Drug Sodium Nitroprusside Injection
8/13/2018
Medicure Inc.. ("Medicure" or the "Company") (TSXV:MPH, OTC:MCUJF), a cardiovascular pharmaceutical company, is pleased to announce that the Food and Drug Administration (FDA) has approved its Abbreviated New Drug Application ("ANDA") for Sodium Nitroprusside Injection 50 mg/2 mL (25 mg/mL) single dose vial ("SNP"), a generic intravenous cardiovascular drug product.
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Information Update - Health Canada Warns Canadians of New Safety Information Related to Long-Term Use of Azithromycin Following Stem Cell Transplants in Cancer Treatment
8/13/2018
Health Canada is warning Canadians of the potential risk of cancer relapse in patients with cancer of the blood and lymph nodes who have undergone stem cell transplant and are taking long-term azithromycin (Zithromax).
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/C O R R E C T I O N -- Natural Cycles/
8/13/2018
In the news release, US Food And Drug Administration (FDA) Clears Natural Cycles As The First Digital Method Of Birth Control In The United States, issued Aug. 13, 2018 by Natural Cycles over PR Newswire, we are advised by the company that changes have been made to the text of the release.
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FDA Grants Breakthrough Therapy Designation for Xolair (Omalizumab) for Food Allergies
8/13/2018
There are currently no FDA-approved treatments that help prevent severe reactions due to food allergies
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Tarrytown, N.Y.-based Regeneron received some unwelcome news. The U.S. Food and Drug Administration (FDA) rejected the company’s attempt to secure a supplemental approval for its blockbuster drug Eylea as a once-per 12-week treatment for wet age-related macular degeneration (wet AMD).
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Four months after acquiring GlaxoSmithKline’s rare disease gene therapy portfolio, U.K.-based Orchard Therapeutics secured $150 million in an oversubscribed Series C funding round. The funds will be used to advance three late-stage programs that it gained from the deal with GSK.
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This morning Genentech announced the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to Xolair to treat exposure to those deadly food allergies.
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This week had three important target action dates, known as Prescription Drug User Fee Act (PDUFA) dates, for the U.S. Food and Drug Administration (FDA). The agency got ahead of its schedule and approved all of these drugs ahead of schedule. Let’s take a look.
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The U.S. Food and Drug Administration (FDA) approved Alnylam Pharmaceuticals’ Onpattro (patisiran) for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults. It is the first and only RNA interference (RNAi) therapeutic to ever be approved.
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Alnylam Announces First-Ever FDA Approval of an RNAi Therapeutic, ONPATTRO™ (patisiran) for the Treatment of the Polyneuropathy of Hereditary Transthyretin-Mediated Amyloidosis in Adults
8/10/2018
First and Only FDA-approved Treatment Available in the United States for this Indication
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FDA Approves the First One-Year Contraceptive Fully under a Woman's Control
8/10/2018
New Population Council-Developed Product Expands Family Planning Options
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FDA allows marketing of first direct-to-consumer app for contraceptive use to prevent pregnancy
8/10/2018
The U.S. Food and Drug Administration today permitted marketing of the first mobile medical application (app) that can be used as a method of contraception to prevent pregnancy.
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FDA approves new vaginal ring for one year of birth control
8/10/2018
The U.S. Food and Drug Administration today approved Annovera (segesterone acetate and ethinyl estradiol vaginal system), which is a combined hormonal contraceptive for women of reproductive age used to prevent pregnancy and is the first vaginal ring contraceptive that can be used for an entire year.
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Emergent BioSolutions, headquartered in Gaithersburg, Maryland, inked a deal to buy PaxVax, based in Redwood City, California, for $270 million in cash.