Food and Drug Administration (FDA)
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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.
26314 articles about Food and Drug Administration (FDA)
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Sequel’s twiist™ Automated Insulin Delivery System Receives FDA 510(k) Clearance
3/18/2024
Sequel Med Tech, LLC, a company developing state-of-the-art insulin delivery technologies, announced its partner, DEKA Research & Development Corp., has received 510 clearance from the U.S. Food and Drug Administration for the innovative twiist™ Automated Insulin Delivery system powered by Tidepool.
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FDA Roundup: March 15, 2024
3/15/2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
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FDA Advisory Committee Votes in Favor of Bristol Myers Squibb’s and 2seventy bio’s Abecma for Triple-Class Exposed Multiple Myeloma in Earlier Lines of Therapy
3/15/2024
FDA Advisory Committee Votes in Favor of Bristol Myers Squibb’s and 2seventy bio’s Abecma for Triple-Class Exposed Multiple Myeloma in Earlier Lines of Therapy.
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Geron Announces FDA Oncologic Drugs Advisory Committee Votes in Favor of the Clinical Benefit/Risk Profile of Imetelstat for the Treatment of Transfusion-Dependent Anemia in Patients with Lower-Risk MDS
3/14/2024
Geron Corporation announced that the U.S. Food and Drug Administration Oncologic Drugs Advisory Committee voted 12 to 2 in favor of the clinical benefit/risk profile of imetelstat for the treatment of transfusion-dependent anemia in adult patients with low-to-intermediate-1 risk myelodysplastic syndromes who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents.
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Keros Therapeutics Announces U.S. FDA Fast Track Designation for KER-050 in Lower-Risk Myelodysplastic Syndromes
3/14/2024
Keros Therapeutics, Inc. today announced that the U.S. Food and Drug Administration (“FDA”) has granted Fast Track designation for KER-050 for the treatment of anemia in adult patients with very low-, low-, or intermediate-risk myelodysplastic syndromes (“MDS”).
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Ventris Medical Receives 510(k) Additional Clearance for Amplify® Standalone Bone Graft Putty
3/13/2024
Ventris Medical today announced that the United States Food and Drug Administration has granted 510(k) clearance in the intervertebral disc space for Synthetic Bone Graft Putty (Amplify®).
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SetPoint Medical Receives FDA Breakthrough Device Designation for its Neuroimmune Modulation Platform for the Treatment of Multiple Sclerosis
3/13/2024
SetPoint Medical Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for the use of its novel neuroimmune modulation platform for people living with relapsing-remitting multiple sclerosis (RRMS).
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PureTech Receives Orphan Drug Designation for LYT-200 in Acute Myeloid Leukemia
3/13/2024
PureTech Health plc, a clinical-stage biotherapeutics company dedicated to changing the lives of patients with devastating diseases, announced that the U.S. Food and Drug Administration has granted orphan drug designation to LYT-200 for the treatment of AML.
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Positive Feedback From the EMA and FDA on Alzprotect's Phase 2b/3 Development Strategy for PSP
3/13/2024
ALZPROTECT is thrilled to announce that it has received favorable feedback from both the American and European authorities regarding the regulatory path for advancing the clinical development of Ezeprogind/AZP2006 for patients with PSP.
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PepGen Receives U.S. FDA Orphan Drug and Rare Pediatric Disease Designations for PGN-EDO51 for the Treatment of Duchenne Muscular Dystrophy
3/13/2024
PepGen Inc. announced that the U.S. Food and Drug Administration granted both orphan drug and rare pediatric disease designations for PGN-EDO51, an investigational therapeutic for Duchenne muscular dystrophy patients whose mutations are amenable to an exon 51 skipping approach.
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Pacira BioSciences Announces PCRX-201 Granted Regenerative Medicine Advance Therapy (RMAT) Designation for the Treatment of Osteoarthritis of the Knee
3/13/2024
Pacira BioSciences, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to PCRX-201.
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IMUNON Files IND Application to Begin Human Testing of IMNN-101
3/13/2024
IMUNON, Inc. announces it has filed an Investigational New Drug application with the U.S. Food and Drug Administration for IMNN-101 for a Phase 1 clinical study with a seasonal COVID-19 booster vaccine.
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FDA Roundup: March 12, 2024
3/12/2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
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Everest Medicines' Partner Calliditas Therapeutics Announces U.S. FDA Grants an Additional Seven-Year Orphan Drug Exclusivity Period for Nefecon®
3/12/2024
Everest Medicines's licensing partner Calliditas Therapeutics AB announced that the U.S. FDA has granted an orphan drug exclusivity period of seven years for Nefecon®, expiring in December 2030 based on Calliditas obtaining full approval with a new indication for this drug product in December 2023.
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Celltrion USA completes submission of Biologics License Application (BLA) to U.S. FDA for CT-P39, an interchangeable biosimilar candidate of XOLAIR® (omalizumab)
3/11/2024
Celltrion USA announced that the company has submitted a Biologics License Application for CT-P39, an interchangeable biosimilar candidate to XOLAIR® to the U.S. Food and Drug Administration.
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Delta-Fly Pharma Inc.: FDA submission of the protocol of the Phase I/II study of DFP-10917 combined with Venetoclax (VTX) in the AML patients pretreated by VTX involved one regimen
3/11/2024
Following to the previous information on Jan. 30th. in 2024, we are excited to share our latest development status.
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Cepheid Receives FDA Clearance for Xpert® Xpress GBS
3/11/2024
Cepheid announced that it has received clearance from the U.S. Food and Drug Administration for Xpert® Xpress GBS, a dual-target molecular diagnostic test for the qualitative intrapartum detection of Group B Streptococcus.
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Travere Therapeutics Submits Supplemental New Drug Application to the U.S. Food and Drug Administration Seeking Full Approval of FILSPARI® (sparsentan) for the Treatment of IgA Nephropathy (IgAN)
3/11/2024
Travere Therapeutics, Inc. announced the submission of a supplemental New Drug Application to the U.S. Food and Drug Administration for conversion of the existing U.S. accelerated approval of FILSPARI® in IgA nephropathy to full approval.
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Praluent® (alirocumab) Injection Receives FDA Approval to Treat Children with Genetic Form of High Cholesterol
3/11/2024
Regeneron Pharmaceuticals, Inc. announced the U.S. Food & Drug Administration has extended the approval of Praluent® as an adjunct to diet and other low-density lipoprotein cholesterol lowering therapies to include pediatric patients aged 8 and older with heterozygous familial hypercholesterolemia.
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Nurix Therapeutics Announces U.S. FDA Lifts Partial Clinical Hold on NX-2127 Phase 1 TrialNurix cleared to introduce new chirally controlled NX-2127 drug product and resume enrollment of new patients into the study
3/11/2024
Nurix Therapeutics, Inc., a clinical stage biopharmaceutical company developing targeted protein modulation drugs designed to treat patients with cancer and inflammatory diseases, announced that the U.S. Food and Drug Administration has lifted the partial clinical hold on the U.S. Phase 1a/1b study evaluating NX-2127 in adults with relapsed/refractory B-cell malignancies.