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.
18352 articles with Food and Drug Administration (FDA)
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For type 1 narcolepsy, this sleep-wake instability is linked to low levels of hypocretin, also called orexin. Hypocretin is a neurotransmitter produced in the hypothalamus and has a significant role in wakefulness and regulating rapid eye movement (REM) sleep. But Harmony Biosciences has found an...
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The scope of the U.S. Food and Drug Administration’s mission could become much narrower if a proposed restructuring of the federal government comes to fruition.
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A consumer advocacy group, Public Citizen, has petitioned the FDA to pull the drug, Uloric, off the market.
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Voyager Therapeutics Announces FDA Regenerative Medicine Advanced Therapy (RMAT) Designation Granted for VY-AADC for the Treatment of Parkinson’s Disease
6/21/2018
U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation for Voyager’s VY-AADC gene therapy treatment for Parkinson’s disease.
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Former Puma Biotechnology Executive Sentenced to More than Two Years in Prison for Insider Trading
6/21/2018
Robert Gadimian, a former executive with Puma Biotechnology, was sentenced to more than two years in prison for insider trading. -
Tandem Diabetes Care Announces FDA Approval of t:slim X2 Insulin Pump with Basal-IQ Technology
6/21/2018
New Predictive Low Glucose Suspend Feature to Launch with Dexcom G6 CGM System Integration.
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A new report highlights some concerns about the long-term commercial viability of game-changing gene therapies that can radically transform the lives of patients.
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Purdue Pharma, best known for selling painkiller OxyContin, announced it laid off approximately 350 staffers.
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NOCDURNA® (desmopressin acetate) Now Approved by U.S. FDA as First Sublingual Tablet to Treat Nocturia due to Nocturnal Polyuria
6/21/2018
The U.S. Food and Drug Administration (FDA) granted Ferring Pharmaceuticals Inc. approval to market NOCDURNA®.
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Shares of Bedford, Mass.-based Anika Therapeutics have plunged more than 20 percent in premarket trading.
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Array is anxiously awaiting the FDA to approve its combination treatment for BRAF-mutant metastatic melanoma. If approved, Chief Executive Officer Ron Squarer believes it will not only be an important milestone for the company, but also for the patients.
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Cambium Enrolls First Patient in Phase I/II Study to Evaluate Platelet Lysate Biologic for Graft-vs.-Host Disease Dry Eye
6/19/2018
Cambium Medical Technologies (“Cambium”), a clinical stage company, announced today first patient enrollment for its Elate Ocular™.
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Boston-based Emulate closed on a Series C round worth $36 million.
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Ortho Dermatologics, a division of Quebec-based Valeant Pharmaceuticals International, received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for Duobrii for plaque psoriasis.
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Caladrius Receives FDA Regenerative Medicine Advanced Therapy Designation for CD34+ Cell Therapy for Treating Refractory Angina
6/19/2018
Caladrius Biosciences, Inc. announces today that that the U.S. Food and Drug Administration has granted RMAT designation to the Company’s late-stage CD34+ cell therapy program.
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The US FDA Approves First Supplemental Abbreviated New Drug Application (sANDA) for Glenmark Pharmaceuticals' Manufacturing Facility in Monroe, North Carolina
6/18/2018
Glenmark Pharmaceuticals, a global pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) provided its first supplemental Abbreviated New Drug Application (sANDA) approval.
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Ernest Loumaye, chief executive officer of Switzerland-based ObsEva, is excited about the potential opportunity to provide women a significant treatment for endometriosis-associated pain.
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The U.S. Food and Drug Administration (FDA) placed a clinical hold on Boston-based Ziopharm Oncology’s Phase I trial of its Sleeping Beauty CAR-T therapy.
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Shares of Solid Biosciences have jumped 11 percent in premarket trading after the company announced the U.S. Food and Drug Administration has lifted a clinical hold on the company’s Phase I/II clinical trial gene therapy treatment for Duchenne muscular dystrophy (DMD).
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Teva Provides Update on Clinical Trial of Fremanezumab for Use in Chronic Cluster Headache
6/15/2018
Teva Pharmaceutical Industries Ltd. today announced a change in the clinical development program of fremanezumab in chronic cluster headache.