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.
19064 articles with Food and Drug Administration (FDA)
-
It seems like every time we turned around this year, there was an exciting or—on a more visceral level, “Hey, that’s cool!” science story. Here’s a look at the top 9 really cool life science discoveries of the year, from outer space, to peanut allergies, to tortoise genomes.
-
FDA clears mobile medical app to help those with opioid use disorder stay in recovery programs
12/10/2018
Today, the U.S. Food and Drug Administration cleared a mobile medical application (app) to help increase retention (the amount of time a patient participates) in an outpatient treatment program for individuals with opioid use disorder (OUD).
-
What’s Going on With the Biosimilar Market?
12/10/2018
Although a moderate presence in Europe, with about 25 biosimilars approved and on the market, they haven’t gained traction in the U.S. Even though at least 11 have been approved in the U.S., only about three are available, largely because of business tactics branded drug companies are using to sl... -
Contego Medical Receives 510(k) Clearance for the Vanguard IEP Peripheral Angioplasty System with Integrated Embolic Protection
12/7/2018
Contego Medical announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its Vanguard IEP® Peripheral Balloon Angioplasty System with Integrated Embolic Protection.
-
XenoTherapeutics to Start First Human Trial of Xeno-Skin™, a Novel Xenotransplantation Treatment for Severe Burns
12/7/2018
FDA clears XenoTherapeutics’ IND application; Massachusetts General Hospital designated as study center for first-in-human trials
-
New and enhanced features of Planmed Verity® receive FDA approval
12/7/2018
The U.S. Food and Drug Administration (FDA) has issued an approval letter for the new features and intended uses of the Planmed Verity® CBCT scanner. Planmed is very pleased to bring these exciting improvements to the U.S. market.
-
Late Thursday, Genentech said the U.S. Food and Drug Administration granted regulatory approval for a combination of Tecentriq and Avastin for treatment of some metastatic non-squamous non-small cell lung cancer (NSCLC) patients.
-
The U.S. Food and Drug Administration (FDA) released a new 2019 strategic Framework for how it plans to advance the use of so-called real-world data (RWD) to improve regulatory decisions. The agency has indicated that this is a strategic priority.
-
FDA Approves Genentech’s Tecentriq in Combination With Avastin and Chemotherapy for the Initial Treatment of People With a Specific Type of Metastatic Lung Cancer
12/6/2018
Approval based on survival benefit of Tecentriq, in combination with Avastin, paclitaxel and carboplatin (chemotherapy), in people with metastatic non-squamous non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations compared to Avastin plus chemotherapy –
-
The U.S. public apparently believes that drug prices are too high. At the same time, they seem largely opposed to government efforts to control health care costs, alternately supportive and non-supportive of efforts to eliminate the Affordable Care Act, better known as Obamacare.
-
Subtle Medical Receives FDA 510(k) Clearance and CE Mark Approval for SubtlePET™
12/5/2018
First AI Product Cleared for Medical Imaging Enhancement.
-
Innovent Receives an Approval from the US FDA to Initiate Clinical Trials for its Anti-OX40 Monoclonal Antibody IBI101
12/5/2018
Innovent Biologics, Inc. announced today that its IND application for IBI101, a recombinant fully human anti-OX40 monoclonal antibody (mAb) drug candidate, has been approved by the US Food & Drug Administration (FDA), and plans to initiate the US phase I clinical trial based on results from the China phase I study in patients with advanced solid tumors.
-
FDA Grants Priority Review to Genentech’s Tecentriq in Combination with Chemotherapy for the Initial Treatment of Extensive-Stage Small Cell Lung Cancer
12/5/2018
Genentech today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for Tecentriq® (atezolizumab), in combination with carboplatin and etoposide (chemotherapy), for the initial (first-line) treatment of people with extensive-stage small cell lung cancer (ES-SCLC).
-
The FDA is often publishing draft guidelines and asking for expert feedback on that guidance. It’s been a busy week in this regard, with several areas of healthcare and drug development and manufacturing being covered by the agency. Here’s a look.
-
“Humira is an anti-TNF monoclonal antibody that currently treats Crohn's disease, rheumatoid arthritis, ulcerative colitis, hidradenitis suppurativa, psoriasis, psoriatic arthritis, juvenile idiopathic arthritis, ankylosing spondylitis and uveitis,” quotes Humira developer AbbVie’s website. Those...
-
Seattle Genetics and Takeda show off the impressive survival data that prompted the FDA to give approval to Adcetris for this indication.
-
Alma, a Sisram Medical Company, Receives Notice of Completion of Inquiry from FDA for FemiLift[TM] Pixel CO2 System
12/3/2018
Alma Lasers, a global developer of innovative energy-based solutions for the aesthetic and surgical markets, announced today that it received a notice of completion from the Food and Drug Administration (FDA) in response to questions about marketing and promotional language concerning the Company's FemiLift Pixel CO2 system used for dermatological, surgical and gynecological health procedures.
-
Ocular Therapeutix™ Announces FDA Approval of DEXTENZA® for the Treatment of Ocular Pain Following Ophthalmic Surgery
12/3/2018
DEXTENZA® (dexamethasone ophthalmic insert) is the First Intracanalicular Insert Approved by the FDA for Drug Delivery
-
Novartis’ gene therapy treatment for spinal muscular atrophy could see approval as early as May of this year after the U.S. Food and Drug Administration granted AVXS-101, now dubbed Zolgensma, priority review.
-
GlaxoSmithKline announced it will acquire the Tesaro, based in Waltham, Mass., for $5.1 billion. For GSK, the deal marks an increased focus on oncology as it focuses on high growth areas.