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.
22075 articles with Food and Drug Administration (FDA)
-
FoundationOne®CDx Receives FDA-Approval as a Companion Diagnostic for VITRAKVI®(larotrectinib) to Identify Patients with NTRK Fusions Across All Solid Tumors
10/23/2020
FoundationOne ® CDx Receives FDA-Approval as a Companion Diagnostic for VITRAKVI®(larotrectinib) to Identify Patients with NTRK Fusions Across All Solid Tumors CAMBRIDGE, Mass.--( BUSINESS WIRE )-- Foundation Medicine, Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne®CDx to be used as a companion diagnostic for VITRAKVI® (larotrectinib), which is currently FDA-approved for the treatment o
-
GI Supply Gets FDA Clearance for its Submucosal Lifting Agent in a Second Size, a Pre-filled 10mL Syringe
10/23/2020
GI Supply today announced the FDA clearance of EverLift™ Submucosal Lifting Agent in a 10mL syringe , a new device for the lift of polyps, adenomas, early-stage cancers and other gastrointestinal lesions prior
-
FDA Approves FoundationOne®CDx as Companion Diagnostic for Vitrakvi® (larotrectinib), to Aid in Identifying NTRK Fusion-Positive Patients
10/23/2020
Detection of genomic alterations that drive the growth and spread of the tumor can guide treatment decisions for cancer therapies, including available biomarker driven treatments FoundationOne ® CDx analyzes substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes as well as select rearrangements and genomic signatures across all solid tumors, including the three NTRK gene fusions ( NTRK 1, NTRK 2
-
Kezar Life Sciences Announces Orphan Drug Designations for KZR-616 for the Treatment of Polymyositis and Dermatomyositis
10/23/2020
Kezar Life Sciences, Inc., a clinical-stage biotechnology company discovering and developing breakthrough treatments for immune-mediated and oncologic disorders, announced that the U.S. Food and Drug Administration has granted Orphan Drug Designations for KZR-616 for the treatment of polymyositis and dermatomyositis.
-
After discovering promising indicators on the path to the development of Branaplam (LMIO70) for spinal muscular atrophy, Novartis now hopes to repurpose the drug for the treatment of Hungtington’s disease.
-
After nearly a month in limbo, AstraZeneca will resume Phase III testing of its COVID-19 vaccine candidate in the United States.
-
In the meeting, both the FDA and the U.S. Centers for Disease Control and Prevention presented details about COVID-19 and the requirements for a vaccine.
-
Embody, Inc. Announces FDA 510(k) Clearance of TAPESTRY® Biointegrative Implant for Tendon and Ligament Repair
10/22/2020
Embody , Inc., a privately-held medical device company developing novel collagen-based technologies for sports medicine and soft tissue repair, announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its TAPESTRY Biointegrative Implant for tendon and ligament repair. TAPESTRY is a
-
Avioq Announces FDA Approval of VioOne™ HIV Profile™ Supplemental Assay
10/22/2020
Avioq, Inc. announces it has received approval from the U.S. Food and Drug Administration (FDA) for their Vio One™ HIV Profile™ Supplemental Assay. The HIV Profile™ assay is an enzyme-linked immunosorbent assay (ELISA) for confirmation and differentiation of individual antibodies directed to various gene products of HIV-1 (Group
-
Reven Pharmaceuticals Wins FDA Approval of Its IND Application for Treatment of COVID-19 With Rejuveinix (RJX)
10/22/2020
Reven Holdings, Inc. (“Reven”) is a privately held clinical stage biotechnology and pharmaceutical company dedicated to the discovery and development of novel treatment platforms for cancer, viral illnesses—including COVID-19—and inflammatory disorders. Reven today announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application in connection with its lead anti-inf
-
FDA Approves First Treatment for COVID-19
10/22/2020
- Today, the U.S. Food and Drug Administration approved the antiviral drug Veklury (remdesivir) for use in adult and pediatric patients 12 years of age and older and weighing at least 40 kilograms (about 88 pounds) for the treatment of COVID-19 requiring hospitalization. Veklury should only be administered in a hospital or in a
-
Cala Health Receives FDA Breakthrough Device Designation for Cala Trio™ Therapy to Treat Action Tremors in Parkinson's Disease
10/22/2020
Cala Health, Inc. announced that the U.S. Food and Drug Administration has granted Breakthrough Device Designation to Cala Trio™ for the treatment of action tremors in the hands of adults with Parkinson's disease.
-
Adaptive Phage Therapeutics Receives Orphan Drug Designation for PhageBank™ in Prosthetic Joint Infections
10/22/2020
Adaptive Phage Therapeutics Receives Orphan Drug Designation for PhageBank ™ in Prosthetic Joint Infections
-
Nevakar Announces FDA Approval for Ephedrine Sulfate Injection as Ready-to-Use Vials
10/22/2020
Nevakar Inc., a biopharmaceutical company developing multiple assets in the ophthalmic and injectable areas, announced it received approval from the U.S. Food and Drug Administration to market Ephedrine Sulfate Injection in a ready-to-use 50mg/10 ml single use vial presentation.
-
Shares of Gilead Sciences are jumping in aftermarket trading following full approval for Veklury (remdesivir) as a treatment for COVID-19. The approval marks the first drug approved by the U.S. Food and Drug Administration as a treatment for the novel coronavirus.
-
After reviewing its mid-pandemic performance, it became clear that its greatest challenge is around the handling of data, according to Amy P. Abernethy, M.D., Ph.D., principal deputy commissioner, FDA, speaking at the recent Demy-Colton Virtual Salon, the “Fusion of Technologies.”
-
Adicet Announces FDA Clearance of IND Application for First-in-Class Allogeneic CAR Gamma-Delta T Cell TherapyPhase 1 Clinical Study will Evaluate ADI-001 Safety and Efficacy in Patients with B-cell non-Hodgkin’s lymphoma
10/22/2020
Adicet Bio, Inc. announced that the U.S. Food and Drug Administration has cleared the Company’s Investigational New Drug application for ADI-001, an allogeneic gamma delta T cell therapy expressing a chimeric antigen receptor targeting CD20 for treatment of non-Hodgkin’s lymphoma.
-
Adial Pharmaceuticals Announces FDA Reactivation of its Investigational New Drug Application for AD04 in Alcohol Use Disorder
10/21/2020
Adial Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company focused on the development of treatments for addictions, announced that the U.S. Food and Drug Administration has reactivated Adial's U.S. Investigational New Drug application and lifted the clinical hold from AD04, a genetically-targeted therapeutic agent for the treatment of Alcohol Use Disorder.
-
Rare Disease Cures Accelerator-Data and Analytics Platform First Year Milestones Highlighted at Virtual Workshop
10/21/2020
C-Path, NORD, FDA and more come together to showcase the importance of data sharing in rare disease drug development
-
Aidoc granted AI industry-first FDA clearance for triage of incidental pulmonary embolism
10/21/2020
This is the company's 6th FDA clearance and further solidifies its leadership as the most comprehensive acute AI vendor in the market