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.
24805 articles with Food and Drug Administration (FDA)
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The approval, which was made under Priority Review, is a watershed moment in gene therapy as it marks the first FDA green light for a lentiviral vector.
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FDA Approves First Cell-Based Gene Therapy to Treat Adult and Pediatric Patients with Beta-thalassemia Who Require Regular Blood Transfusions
8/17/2022
U.S. Food and Drug Administration approved Zynteglo (betibeglogene autotemcel), the first cell-based gene therapy for the treatment of adult and pediatric patients with beta-thalassemia who require regular red blood cell transfusions.
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FDA Clears ImmunoCAP™ Blood Tests for Wheat and Sesame Allergy
8/17/2022
Today, Thermo Fisher Scientific announces the clearance of ImmunoCAP Specific IgE (sIgE) Allergen Components for wheat and sesame* allergies by the U.S. Food & Drug Administration (FDA) for in vitro diagnostic use.
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The FDA expects to foster innovation and competition among manufacturers, which would lower the prices of hearing aids without compromising their quality.
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ANI Pharmaceuticals Announces FDA Approval and Imminent Launch of Dexamethasone Tablets USP
8/16/2022
ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that the Company received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Application (ANDA) for Dexamethasone Tablets USP 1.5mg, 4mg and 6mg.
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InnerScope Hearing Technologies (OTC: INND) Announces FDA Has Released The Final Rule For OTC Hearing Aids
8/16/2022
InnerScope Hearing Technologies Inc. is pleased to announce that the FDA has released the "Final Rule" for creating a new category of Over-the-Counter hearing aids for perceived mild to moderate hearing losses to be sold directly to consumers in retail stores, pharmacies and online without a medical exam or being fitted by a hearing healthcare professional.
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Novavax seeks EUA for COVID-19 Booster, a 100-year-old TB vaccine may protect against the disease and public health officials struggle with fall planning.
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Amphastar Pharmaceuticals Receives FDA Approval for Epinephrine Pre-Filled Syringes
8/16/2022
Amphastar Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration has approved the Company's New Drug Application for Epinephrine injection USP, 1 mg/10mL Single Dose Pre-Filled Syringe.
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AstraZeneca and Daiichi Sankyo’s Enhertu Racks up Another Clinical Win in Breast Cancer (Updated)
8/15/2022
AstraZeneca and Daiichi Sankyo’s Enhertu has been approved by the FDA as the first HER2-directed medicine for the treatment of patients with HER2-mutant metastatic NSCLC. -
Preceptis Medical Receives FDA Clearance for Expanded Labeling for Hummingbird System
8/15/2022
Preceptis Medical, Inc. today announced U.S. FDA clearance for expanded indications for use for the Hummingbird® Tympanostomy Tube System (TTS) for office-based pediatric ear tube procedures.
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Daewoong Pharmaceutical Announces US FDA Clearance of IND Application for DWP213388, First-in-class Irreversible Oral Dual Acting inhibitor for Autoimmune Diseases
8/15/2022
Daewoong Pharmaceutical is a publicly traded South Korean pharmaceutical company that develops, manufactures, and commercializes pharmaceuticals globally today announced that the U.S. Food and Drug Administration (FDA) has cleared an Investigational New Drug (IND) application to initiate a Phase 1 clinical trial of DWP213388, a new drug candidate being developed for autoimmune diseases.
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This week holds moments of truth for Provention's type 1 diabetes drug and bluebird bio's gene therapy for beta-thalassemia. Amicus and Incyte are coming up at the end of the month.
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Daiichi Sankyo and AstraZeneca report another first-in-class approval for Enhertu, Bayer snags an sNDA in metastatic hormone-sensitive prostate cancer and Merck faces contamination challenges with Januvia.
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FDA Approves First NGS-Based Companion Diagnostic to Aid in Selecting Non-Small Cell Lung Cancer Patients with HER2 (ERBB2) Activating Mutations (SNVs & Exon 20 Insertions) for Treatment with ENHERTU
8/12/2022
The U.S. Food and Drug Administration (FDA) has granted premarket approval to Thermo Fisher Scientific’s Oncomine Dx Target Test as a companion diagnostic (CDx) to identify patients whose tumors have a HER2 (ERBB2) activating mutations (SNVs & Exon 20 Insertion) in non-small cell lung cancer (NSCLC).
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FDA Infant Formula Update: August 10, 2022
8/11/2022
The U.S. Food and Drug Administration is providing an update on additional steps it has taken that will lead to more infant formula available in the U.S. under the agency's recent increased flexibilities.
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Menarini Group's Elacestrant Granted Priority Review by the U.S. FDA for Patients with ER+/HER2- Advanced or Metastatic Breast Cancer
8/11/2022
The Menarini Group and Stemline Therapeutics, a wholly-owned subsidiary of Menarini Group, announced that the U.S. Food and Drug Administration has accepted the Company's New Drug Application for elacestrant, an investigational selective estrogen receptor degrader, for patients with ER+/HER2- advanced or metastatic breast cancer.
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Genentech Announces FDA Approval of Xofluza to Treat Influenza in Children Aged Five and Older
8/11/2022
Genentech, a member of the Roche Group, announced that the U.S. Food and Drug Administration has approved a supplemental New Drug Application for Xofluza® for the treatment of acute uncomplicated influenza in otherwise healthy children aged five to less than 12 years of age who have been symptomatic for no more than 48 hours.
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Menarini Group’s Elacestrant Granted Priority Review by the U.S. FDA for Patients with ER+/HER2- Advanced or Metastatic Breast Cancer
8/11/2022
The Menarini Group and Stemline Therapeutics announced that the U.S. Food and Drug Administration has accepted the Company’s New Drug Application for elacestrant, an investigational selective estrogen receptor degrader, for patients with ER+/HER2- advanced or metastatic breast cancer.
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Roche receives FDA approval for VENTANA MMR RxDx Panel to identify dMMR solid tumour patients and pMMR endometrial cancer patients eligible for KEYTRUDA
8/11/2022
Roche announced US Food and Drug Administration approval of a label expansion for the VENTANA MMR RxDx Panel.
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Larimar Therapeutics Provides Updates on CTI-1601 Clinical Program Following a Type C Meeting with the U.S. Food and Drug Administration and Reports Second Quarter 2022 Operating and Financial Results
8/11/2022
Larimar Therapeutics, Inc. announced that it has received meeting minutes from the U.S. Food and Drug Administration following a recent Type C Meeting with the Agency and reported its second quarter 2022 operating and financial results.