Food and Drug Administration

The Food and Drug Administration is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs, vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices, cosmetics, animal foods & feed and veterinary products. The FDA was empowered by the United States Congress to enforce the Federal Food, Drug, and Cosmetic Act, which serves as the primary focus for the Agency; the FDA also enforces other laws, notably Section 361 of the Public Health Service Act and associated regulations, many of which are not directly related to food or drugs. These include regulating lasers, cellular phones, condoms and control of disease on products ranging from certain household pets to sperm donation for assisted reproduction. The FDA is led by the Commissioner of Food and Drugs, appointed by the President with the advice and consent of the Senate.
Latest trending news and information about the Food and Drug Administration.
  • US makes new push for graphic warning labels on cigarettes
    WSB Radio

    US makes new push for graphic warning labels on cigarettes

    WASHINGTON -  U.S. health officials are making a new attempt at adding graphic images to cigarette packets to discourage Americans from lighting up. If successful, it would be the first change to U.S. cigarette warnings in 35 years. The Food and Drug Administration on Thursday proposed 13 new warnings that would appear on all cigarettes, including images of cancerous neck tumors, diseased lungs and feet with amputated toes. Other color illustrations would warn smokers that cigarettes can cause heart disease, impotence and diabetes. The labels would take up half of the front of cigarette packages and include text warnings, such as "Smoking causes head and neck cancer." The labels would also appear

  • Benzinga

    The Week Ahead In Biotech: FDA Goes Into Overdrive In A Quiet Week

    Biotech stocks succumbed to the broader market weakness, as trade tensions and recession fears shook the broader markets. Earnings and stray clinical readouts triggered some activity in the space. Here ...

  • FDA: Fresh basil from Mexico linked to outbreak of intestinal illness
    WSB Radio

    FDA: Fresh basil from Mexico linked to outbreak of intestinal illness

    Fresh basil from Mexico is linked to an outbreak of an intestinal illness affecting 200 people in 11 states across the country.  Five people were hospitalized after eating basil from Siga Logistics de RL de CV, from Morelos, Mexico, according to the Food and Drug Administration.  The illness, cyclospora cayetanensis, is a type of parasite transmitted from infected feces. It takes about a week to see symptoms, which include diarrhea, loss of appetite and nausea. Georgia, Florida, Ohio, New York and Massachusetts are among the states where cases have been reported.  Siga Logistics de RL de CV previously recalled the basil July 24. Food safety officials recommend consumers throw away any basil from

  • Here's why Novartis CEO thinks FDA process could have been handled better
    Business Standard India

    Here's why Novartis CEO thinks FDA process could have been handled better

    Novartis AG Chief Executive Officer Vas Narasimhan said the company could have handled a furor surrounding its Zolgensma gene therapy better. Narasimhan, who became CEO of the pharmaceutical manufacturer last year, made the comment in a company call with 12,000 managers, according to newspaper Schweiz am Wochenende. Looking back, Narasimhan said he recognized opportunities where Novartis could have handled the situation better. Narasimhan said he is not perfect as a CEO and “we will all keep working on it.” The Swiss company is under fire from US lawmakers who say it should have told regulators about data irregularities before the drug's approval in May, rather than waiting to conclude an internal

  • MedicineNet.com

    FDA Approves Drug for Most Deadly Form of TB

    THURSDAY, Aug. 15, 2019 (HealthDay News) -- A new drug has been approved as part of a powerful, three-pronged treatment regimen for the most deadly strain of tuberculosis, the U.S. Food and Drug Administration announced Wednesday. Pretomanid tablets were approved to be used with bedaquiline and linezolid in adults with extensive multidrug-resistant tuberculosis (XDR-TB) of the lungs. Caused by a bacterium that attacks the lungs, TB can also wreak havoc on any part of the body including the kidney, spine and brain. The FDA approval sprang from a groundbreaking trial of 107 patients in South Africa who had been diagnosed with XDR-TB. Six months after treatment, 89% of the patients were cured, which

  • Zimmer Biomet's Innovative Treatment for Young Patients with Scoliosis Receives FDA Approval
    PR Newswire

    Zimmer Biomet's Innovative Treatment for Young Patients with Scoliosis Receives FDA Approval

    WARSAW, Ind., Aug. 16, 2019 /PRNewswire/ -- Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced U.S. Food and Drug Administration approval for The Tether™ for treatment of scoliosis, providing a fusion-less alternative for young patients requiring surgery. The current surgical treatment for scoliosis is an invasive operation involving large incisions, extensive soft tissue disruption and restriction of spinal motion with metal rods inserted along both sides of the spine to secure and align the vertebrae. Surgeons have tirelessly searched for alternative non-fusion surgical approaches to address scoliosis without limiting the skeletal development of these patients who are active and still growing. Zimmer Biomet's anterior vertebral body tethering (AVBT) solution, The Tether, uses a strong, flexible cord, rather than metal rods, to pull on the outside of a scoliosis curve to initially straighten the spine, while the inside of the curve is left free to grow.

  • the Guardian

    Group to tout bleach-based 'miracle cure' at upstate New York 'seminar'

    Advocates of a “medicine” called MMS will gather in a hotel in upstate New York on Saturday to promote what they claim to be a miracle cure for cancer that is in fact a powerful bleach that can cause serious harm and even death. The self-proclaimed “Genesis II Church of Health and Healing” – a group that in reality is neither a church nor a medical outfit – plans to lure supporters and unsuspecting individuals to a “seminar” at the Marienthal Country Inn in Eden, New York. It is charging $450 per person, or $800 for a couple, for the privilege of being inculcated over two days into the false promises of its remedy, “miracle mineral solution” or MMS. A document seen by the Guardian shows that the group intends to provide the industrial-strength bleach to attendants for them to drink.

  • Reuters

    UPDATE 1-Edwards Lifesciences, Medtronic heart valves win U.S. approval for expanded use

    Heart valve systems from Edwards Lifesciences Corp and Medtronic Plc have been approved for use in a condition that restricts blood flow from the heart in patients at low-risk of death linked to open-heart surgeries, the U.S. FDA said on Friday. The Food and Drug Administration approved two of Edwards' transcatheter heart valve systems called Sapien 3 And Sapien 3 Ultra as well as Medtronic's Evolut Transcatheter Aortic Valve Replacement (TAVR)system.

  • Benzinga

    Nabriva Shares Volatile As Biopharma Updates FDA Filing Timeline

    Following the receipt of the final minutes of a Type A meeting Nabriva had with the FDA, the company said it expects to resubmit the NDA for injectable Contepo — which is being evaluated for complicated urinary tract infections, including acute pyelonephritis — early in the fourth quarter of 2019. Nabriva's original NDA was accepted by the FDA for priority review Jan. 4, with a PDUFA action date of June 30. The FDA, however, handed down a complete response letter to the NDA April 30, urging the company to address issues related to facility inspections and deficiencies at one of the company's manufacturers.

  • Koch Acquires German Distributor; UK Org FDA Appoints Former STX Exec — Global Briefs
    Deadline

    Koch Acquires German Distributor; UK Org FDA Appoints Former STX Exec — Global Briefs

    In a sign of further consolidation in the German movie market Koch Films has acquired fellow indie distributor KSM, whose managing director Benjamin Krause has handed over full control of the label to Koch managing directors Jochen Walter and Stefan Kapelari. KSM, a leading anime distributor in Germany, has also released movies including Love & […]

  • Pharma Stock Roundup: Pipeline/Regulatory Updates From JNJ, LLY, AZN, RHHBY
    Zacks

    Pharma Stock Roundup: Pipeline/Regulatory Updates From JNJ, LLY, AZN, RHHBY

    FDA approves Roche's (RHHBY) tumor-agnostic medicine, Rozlytrek, J&J's Sirturo for young TB patients.

  • How AbbVie Plans To Take On Pfizer, Lilly — And Kick Its Humira Habit
    Investor's Business Daily

    How AbbVie Plans To Take On Pfizer, Lilly — And Kick Its Humira Habit

    Shares of AbbVie leapt higher Friday after the Food and Drug Administration approved its new rheumatoid arthritis treatment — a potential rival to drugs from Eli Lilly and Pfizer.

  • Business Standard India

    Lupin gets USFDA nod for its skin conditions cream

    Drug firm Lupin on Friday said it has received approval from the US health regulator for generic Hydrocortisone Valerate cream used for relief from inflammation and itching due to various skin conditions. The company has got approval for its Hydrocortisone Valerate cream USP, 0.2 per cent from the United States Food and Drug Administration (USFDA), Lupin said in a filing to the BSE. The product is generic version of Sun Pharmaceutical Industries Ltd's Westcort cream in the same strength, it added. The cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in adult patients, Lupin said. Shares of Lupin Ltd on Friday ended at Rs

  • Five-Year FDA IDE Trial Outcomes Show a Higher Safety Profile and Greater Effectiveness at Preserving Range of Motion for the activL® Artificial Disc Compared to Previous Generation Lumbar Discs
    PR Newswire

    Five-Year FDA IDE Trial Outcomes Show a Higher Safety Profile and Greater Effectiveness at Preserving Range of Motion for the activL® Artificial Disc Compared to Previous Generation Lumbar Discs

    CENTER VALLEY, Pa., Aug. 15, 2019 /PRNewswire/ -- Aesculap Implant Systems, LLC, a leader in lumbar motion preservation technology, today announced the e-publication of the "Five-year results of a randomized controlled trial for lumbar artificial discs in single level degenerative disc disease" in Spine. The five-year study reports the outcomes of 261 patients at five years post procedure comparing the activL Artificial Disc, the latest generation Lumbar Total Disc Replacement (TDR), with the previous generation disc replacement systems — ProDisc-L and Charité — in the treatment of patients with symptomatic single-level lumbar degenerative disc disease (DDD). Also, an indirect comparison of TDR patients with fusion patients provides further insight into the relationship between range of motion (ROM) and adjacent segment disease (ASD).

  • FDA Romaine Tests Find No Worrisome Bacteria
    ConsumerReports.org

    FDA Romaine Tests Find No Worrisome Bacteria

    The Food and Drug Administration said Wednesday that its testing of romaine lettuce in the Yuma, Ariz., growing region, where lettuce linked to a major E. coli outbreak in 2018 was grown, found j...