News Archive of FDA Press Releases

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FDA approves first-of-its-kind corneal implant to improve near vision in certain patients04-17-15
FDA approves first generic Copaxone to treat multiple sclerosis04-16-15
U.S. Marshals seize unapproved drugs from Florida distributor04-16-15
FDA approves Corlanor to treat heart failure04-15-15
FDA warns consumers not to use muscle growth product called Tri-Methyl Xtreme04-13-15
FDA approves breath test to aid in diagnosis of delayed gastric emptying04-06-15
Massachusetts dairy operation agrees to permanent injunction to prevent illegal drug residues in animals sold for food04-03-15
FDA alerts health care professionals and patients not to use products from the Prescription Center pharmacy in Fayetteville, N.C.04-02-15
FDA issues final guidance on the evaluation and labeling of abuse-deterrent opioids04-01-15
FDA expands use of CoreValve System for aortic ?valve-in-valve? replacement03-30-15
California seafood company to cease production of adulterated fish03-30-15
FDA approves new treatment for diabetic retinopathy in patients with diabetic macular edema03-25-15
FDA approves treatment for inhalation anthrax03-25-15
FDA approves blood pump system to help patients maintain stable heart function during certain high-risk cardiac procedures03-23-15
FDA concludes Arctic Apples and Innate Potatoes are safe for consumption03-20-15
FDA approves Cholbam to treat rare bile acid synthesis disorders03-17-15
FDA releases final guidance on reprocessing of reusable medical devices03-12-15
Federal judge enters consent decree against Specialty Compounding LLC03-11-15
FDA approves first therapy for high-risk neuroblastoma03-10-15
FDA approves CPR devices that may increase chance of surviving cardiac arrest03-09-15
FDA approves new antifungal drug Cresemba03-06-15
FDA authorizes use of first device to treat patients with dialysis-related amyloidosis03-06-15
FDA approves first biosimilar product Zarxio03-06-15
FDA expands approved use of Opdivo to treat lung cancer03-04-15
FDA launches drug shortages mobile app03-04-15
FDA approves new antibacterial drug Avycaz02-25-15
FDA approves Farydak for treatment of multiple myeloma02-23-15
FDA approves closure system to permanently treat varicose veins02-20-15
FDA permits marketing of first direct-to-consumer genetic carrier test for Bloom syndrome02-19-15
FDA issues new draft documents related to compounding of human drugs02-13-15
FDA approves Lenvima for a type of thyroid cancer02-13-15
California food company to cease operations for repeated food safety violations02-12-15
FDA permits marketing of fecal incontinence device for women02-12-15
New data shows test can help physicians remove patients with suspected TB from isolation earlier02-12-15
FDA clears system to reduce stroke risk during stent and angioplasty procedures02-09-15
FDA approves Lucentis to treat diabetic retinopathy in patients with diabetic macular edema02-06-15
Federal judge approves consent decree with Maquet Holding B.V. & Co.02-04-15
FDA approves first molecular (gene-based) test to determine red blood cell types in transfusion medicine05-21-14
FDA approves Entyvio to treat ulcerative colitis and Crohn's disease05-20-14
U.S. Marshals seize unapproved drugs from Ohio distributor05-16-14
FDA requiring lower starting dose for sleep drug Lunesta05-15-14
FDA allows marketing of first prosthetic arm that translates signals from person’s muscles to perform complex tasks05-09-14
FDA approves Zontivity to reduce the risk of heart attacks and stroke in high-risk patients05-08-14
United States enters consent decree with New York cheese producer due to Listeria contamination04-29-14
FDA approves Zykadia for late-stage lung cancer04-29-14
FDA issues proposals to address risks associated with surgical mesh for transvaginal repair of pelvic organ prolapse04-29-14
FDA approves first human papillomavirus test for primary cervical cancer screening04-24-14
FDA proposes to extend its tobacco authority to additional tobacco products, including e-cigarettes04-24-14
FDA approves Sylvant for rare Castleman's disease04-23-14
FDA proposes new expedited access program for medical devices that address unmet medical needs04-22-14
FDA approves Cyramza for stomach cancer04-21-14
FDA approves Ragwitek for short ragweed pollen allergies04-17-14
FDA discourages use of laparoscopic power morcellation for removal of uterus or uterine fibroids04-17-14
Puerto Rico bakery agrees to stop manufacturing and distributing products04-16-14
FDA approves Tanzeum to treat type 2 diabetes04-15-14
FDA approves expanded indication for certain pacemakers and defibrillators04-10-14
FDA warns consumers not to use Zi Xiu Tang Bee Pollen capsules04-07-14
FDA allows marketing for first-of-kind dressing to control bleeding from certain battlefield wounds04-03-14
Proposed health IT strategy aims to promote innovation, protect patients, and avoid regulatory duplication04-03-14
FDA Commissioner Margaret A. Hamburg Statement on Prescription Opioid Abuse04-03-14
FDA approves new hand-held auto-injector to reverse opioid overdose04-03-14
FDA approves first sublingual allergen extract for the treatment of certain grass pollen allergies04-02-14
FDA approves first long-acting recombinant coagulation Factor IX concentrate for patients with Hemophilia B03-28-14
FDA approves Topamax for migraine prevention in adolescents03-28-14
FDA orders Wash.-based smoked seafood manufacturer to cease operations03-28-14
FDA approves Otezla to treat psoriatic arthritis03-21-14
FDA approves first implantable hearing device for adults with a certain kind of hearing loss03-20-14
FDA approves Impavido to treat tropical disease leishmaniasis03-19-14
Some lots of Simply Lite brand dark chocolate recalled03-17-14
FDA allows marketing of first medical device to prevent migraine headaches03-11-14
FDA proposes updates to Nutrition Facts label on food packages02-27-14
FDA approves Myalept to treat rare metabolic disease02-25-14
FDA issues first orders to stop sale, distribution of tobacco products02-21-14
FDA and European Medicines Agency strengthen collaboration in pharmacovigilance area02-19-14
FDA approves Northera to treat neurogenic orthostatic hypotension02-18-14
FDA initiates the Secure Supply Chain Pilot Program to enhance security of imported drugs02-18-14
FDA approves Vimizim to treat rare congenital enzyme disorder02-14-14
Illegal prescription drug sellers arraigned on charges for smuggling illicit cancer drugs into the United States02-13-14
FDA approves Imbruvica to treat chronic lymphocytic leukemia02-12-14
FDA warns against using Uncle Ben’s Infused Rice02-10-14
Updated FDA requirements for infant formula will maintain high-quality standards and help ensure healthy growth of infants02-06-14
FDA Commissioner Hamburg travels to India02-05-14
FDA launches its first national public education campaign to prevent, reduce youth tobacco use02-04-14
FDA approves pediatric use of Dexcom’s G4 Platinum continuous glucose monitoring system02-03-14
FDA Approves Hetlioz: first treatment for non-24 hour sleep-wake disorder in blind individuals01-31-14
FDA proposes rule to prevent food safety risks during transportation01-31-14
FDA Statement on Western Sugar Cooperative voluntary recall of beet pulp and tailings01-28-14
FDA prohibits Ranbaxy's Toansa, India facility from producing and distributing drugs for the U.S. market01-23-14
FDA launches advisory committee membership nomination portal01-22-14
FDA warns consumers not to eat oysters from Copano Bay in Aransas County, Texas01-17-14
FDA Deputy Commissioner for Foods and Veterinary Medicine Michael R. Taylor's Statement on the Institute of Medicine Report on Caffeine in Food and Dietary Supplements01-17-14
FDA allows marketing for first of-its-kind post-natal test to help diagnose developmental delays and intellectual disabilities in children01-17-14
FDA Commissioner Margaret A. Hamburg's Statement on the 50th Anniversary Surgeon General's Report on Smoking and Health01-17-14
FDA approves Mekinist in combination with Tafinlar for advanced melanoma01-10-14
FDA approves first gel for sealing corneal incision after cataract surgery01-09-14
FDA approves Farxiga to treat type 2 diabetes01-08-14
FDA warns consumers not to use muscle growth product12-23-13
FDA approves Tretten to treat rare genetic clotting disorder12-23-13
FDA announces voluntary nationwide recall of all non-expired sterile drugs from Abrams Royal Compounding Pharmacy12-21-13
FDA proposes new food defense rule12-20-13
Montana dietary supplement maker found in contempt of court12-19-13
FDA allows marketing of new stent for treating pseudocysts of the pancreas12-18-13
FDA approves Anoro Ellipta to treat chronic obstructive pulmonary disease12-18-13
FDA and European Medicines Agency launch generic drug application inspections initiative12-18-13
FDA issues proposed rule to determine safety and effectiveness of antibacterial soaps12-16-13
FDA approves first drug treatment for Peyronie’s disease12-06-13
FDA proposes new food defense rule12-20-13
Montana dietary supplement maker found in contempt of court12-19-13
FDA allows marketing of four ?next generation? gene sequencing devices11-19-13
FDA issues proposed rule to determine safety and effectiveness of antibacterial soaps12-16-13
FDA allows marketing of new stent for treating pseudocysts of the pancreas12-18-13
FDA approves Anoro Ellipta to treat chronic obstructive pulmonary disease12-18-13
FDA and European Medicines Agency launch generic drug application inspections initiative12-18-13
FDA allows marketing of first device to relieve migraine headache pain12-13-13
FDA approves first generic versions of antidepressant drug Cymbalta12-11-13
FDA takes significant steps to address antimicrobial resistance12-11-13
FDA approves Sovaldi for chronic hepatitis C12-06-13
FDA approves first drug treatment for Peyronie's disease12-06-13
FDA reaches $1.25 million settlement with Advanced Sterilization Products and company executives12-04-13
FDA issues safety communication on HeartStart automated external defibrillators from Philips Healthcare12-03-13
FDA study helps provide an understanding of rising rates of whooping cough and response to vaccination11-27-13
Court order keeps food company from production until it cleans up11-27-13
FDA requires removal of certain restrictions on the diabetes drug Avandia11-25-13
FDA approves new treatment for hepatitis C virus11-22-13
FDA approves first adjuvanted vaccine for prevention of H5N1 avian influenza11-22-13
FDA approves Nexavar to treat type of thyroid cancer11-22-13
FDA allows marketing of four “next generation” gene sequencing devices11-19-13
U.S. Marshals seize more than $2 million in adulterated dietary supplements from Georgia company11-18-13
FDA approves medical device to treat epilepsy11-14-13
FDA approves Imbruvica for rare blood cancer11-13-13
USPlabs LLC recalls OxyElite Pro dietary supplements; products linked to liver illnesses11-10-13
FDA approves Aptiom to treat seizures in adults11-08-13
FDA approves first generic versions of Aciphex delayed-release tablets to treat GERD11-08-13
FDA takes action to speed safety information updates on generic drugs11-08-13
FDA takes step to further reduce trans fats in processed foods11-07-13
FDA: Janssen Pharmaceuticals, Inc. to plead guilty and pay over $1.6 billion to resolve allegations of misbranding and filing false claims for its schizophrenia drug Risperdal11-04-13
FDA approves Gazyva for chronic lymphocytic leukemia11-01-13
FDA takes two important actions on drug shortages10-31-13
FDA approves extended-release, single-entity hydrocodone product10-25-13
FDA approves second brain imaging drug to help evaluate patients for Alzheimer's disease, dementia10-25-13
FDA issues proposed rule to help ensure the safety of food for animals10-25-13
FDA to complete phase-out of chlorofluorocarbon inhalers10-23-13
FDA announces voluntary recall of certain sterile products from Specialty Medicine Compounding Pharmacy10-22-13
FDA takes enforcement action against Oregon dietary supplement manufacturer10-21-13
FDA awards 15 grants to stimulate drug, device development for rare diseases10-21-13
FDA approves Opsumit to treat pulmonary arterial hypertension10-18-13
FDA approves new pediatric use for Liposorber Apheresis System10-10-13
FDA approves Adempas to treat pulmonary hypertension10-08-13
FDA approves Clinolipid for intravenous nutrition10-04-13
FDA approves new drug to treat major depressive disorder09-30-13
FDA approves Perjeta for neoadjuvant breast cancer treatment09-30-13
FDA awards seven grants to stimulate development of pediatric medical devices09-25-13
FDA approval expands access to artificial heart valve for inoperable patients09-23-13
FDA issues final guidance on mobile medical apps09-23-13
U.S. Marshals seize food products at two Virginia food companies09-20-13
FDA finalizes new system to identify medical devices09-20-13
FDA and NIH create first-of-kind Tobacco Centers of Regulatory Science09-19-13
Federal judge approves consent decree against Shamrock Medical Solutions Group09-18-13
FDA approves first generic capecitabine to treat colorectal and breast cancers09-16-13
FDA prohibits manufacture of FDA-regulated drugs from Ranbaxy's Mohali, India, plant and issues import alert09-16-13
New medical device treats urinary symptoms related to enlarged prostate09-13-13
FDA approves Botox Cosmetic to improve the appearance of crow’s feet lines09-11-13
FDA announces safety labeling changes and postmarket study requirements for extended-release and long-acting opioid analgesics09-10-13
FDA approves Abraxane for late-stage pancreatic cancer09-06-13
Federal judge grants FDA request for consent decree with Idaho farm09-06-13
Federal judge approves consent decree against Dakota Laboratories09-03-13
New test system identifies 193 different yeasts and bacteria known to cause illness08-21-13
FDA reminds health care providers not to use sterile products from NuVision Pharmacy08-16-13
FDA approves new drug to treat HIV infection08-12-13
La FDA aprueba nuevo medicamento para el tratamiento de la infección de VIH08-12-13
FDA awards contract to develop promising new technology to test radiation countermeasures08-12-13
FDA announces nationwide voluntary recall of all products for sterile use from Specialty Compounding08-11-13
FDA approves first rapid diagnostic test to detect both HIV-1 antigen and HIV-1/2 antibodies08-08-13
FDA defines “gluten-free” for food labeling08-02-13
FDA announces a voluntary recall of Nova Max Blood Glucose Test Strips07-31-13
FDA warns consumers about health risks with Healthy Life Chemistry dietary supplement07-26-13
FDA takes step to help ensure the safety of imported food07-26-13
FDA permits marketing of first U.S. test labeled for simultaneous detection of tuberculosis bacteria and resistance to the antibiotic rifampin07-25-13
FDA alerts companies to stop illegal sale of treatments for diabetes07-23-13
FDA invites public input on menthol in cigarettes07-23-13
FDA permits marketing of first brain wave test to help assess children and teens for ADHD07-15-13
FDA permits marketing of quicker method for checking effectiveness of medical device steam sterilization07-12-13
FDA approves new treatment for a type of late-stage lung cancer07-12-13
FDA proposes “action level” for arsenic in apple juice07-12-13
FDA, Justice Department takes action against Vermont dairy farm07-09-13
FDA to detain pomegranate seeds offered for import from Goknur of Turkey06-29-13
FDA approves the first non-hormonal treatment for hot flashes associated with menopause06-28-13
Federal judge enters consent decree with Med Prep Consulting06-28-13
FDA approves first recombinant coagulation factor IX that is specifically indicated for routine use in preventing bleeding episodes (prophylaxis)06-27-13
FDA takes action to protect consumers from dangerous medicines sold by illegal online pharmacies06-27-13
FDA announces first decisions on new tobacco products through the substantial equivalence pathway06-25-13
FDA approves Vibativ for hospitalized patients with bacterial pneumonia06-21-13
FDA obtains waiver from European Commission to facilitate export for U.S. pharmaceutical manufacturers06-21-13
FDA approves Plan B One-Step emergency contraceptive for use without a prescription for all women of child-bearing potential06-20-13
DOJ News Release: The Department of Justice Files Suit Against Louisiana Pharmaceutical Company for Distributing Unapproved and Misbranded Prescription and Over-the-counter Drugs06-20-13
FDA approves first genotyping test for patients with hepatitis C virus06-20-13
FDA approves a new silicone gel-filled breast implant06-14-13
FDA approves Xgeva to treat giant cell tumor of the bone06-13-13
FDA approves two drugs, companion diagnostic test for advanced skin cancer05-29-13
FDA announces import of injectable nutrition drugs05-29-13
FDA clears first blood tracking device that uses Radio Frequency Identification technology05-28-13
FDA alerts health care providers of adverse reactions associated with steroid injections from Main Street Family Pharmacy in Tennessee05-24-13
FDA allows marketing of first A1c test labeled for diagnosing diabetes05-23-13
FDA expands alert to health care providers about lack of sterility assurance of all sterile drug products from NuVision Pharmacy05-18-13
FDA seeks preliminary injunction against New York fish manufacturer05-17-13
FDA approves Simponi to treat ulcerative colitis05-15-13
FDA approves new drug for advanced prostate cancer05-15-13
FDA approves Nymalize--first nimodipine oral solution for use in certain brain hemorrhage patients05-14-13
FDA approves first companion diagnostic to detect gene mutation associated with a type of lung cancer05-14-13
FDA releases new tool to help prevent intentional food contamination05-13-13
FDA warns consumers about potential health risk with Juices Incorporated juice products05-10-13
FDA approves Breo Ellipta to treat chronic obstructive pulmonary disease05-10-13
FDA alerts health care providers of lack of sterility assurance of drug products from The Compounding Shop05-08-13
FDA issues proposal to increase consumer awareness of tanning bed risks05-06-13
FDA warns pregnant women to not use certain migraine prevention medicines05-06-13
FDA approves Plan B One-Step emergency contraceptive without a prescription for women 15 years of age and older04-30-13
FDA approves Procysbi for rare genetic condition04-30-13
FDA approves Kcentra for the urgent reversal of anticoagulation in adults with major bleeding04-29-13
FDA launches partnership to protect against counterfeit anti-malarial medicines with FDA-developed handheld detection tool04-24-13
FDA announces voluntary nationwide recall by Balanced Solutions Compounding Pharmacy04-21-13
FDA approves abuse-deterrent labeling for reformulated OxyContin04-16-13
FDA issues alert about lack of sterility assurance of drug products from ApotheCure, Inc. and NuVision Pharmacy and of forthcoming recall04-16-13
FDA: U.S. Marshals seize food at New York-based food facility04-15-13
FDA budget requests $4.7 billion to ensure safety of food supply and to modernize medical product safety04-10-13
FDA approves Diclegis for pregnant women experiencing nausea and vomiting04-08-13
FDA approves Invokana to treat type 2 diabetes03-29-13
FDA approves new multiple sclerosis treatment: Tecfidera03-27-13
FDA approves first Botulism Antitoxin for use in neutralizing all seven known botulinum nerve toxin serotypes03-22-13
FDA approves TOBI Podhaler to treat a type of bacterial lung infection in cystic fibrosis patients03-22-13
FDA issues proposal to improve the quality of automated external defibrillators03-22-13
FDA alerts health care providers and patients of the nationwide recall of all lots of sterile products distributed by Clinical Specialties Compounding Pharmacy03-21-13
FDA approves Dotarem, a new magnetic resonance imaging agent03-20-13
FDA alerts health care providers of recall of all sterile drug products by Med Prep Consulting in New Jersey03-18-13
FDA warns consumers not to eat certain ProtiDiet High Protein Chocolate Dream Bars manufactured by Pro-Amino International, Inc., Quebec, Canada03-18-13
FDA approves Lymphoseek to help locate lymph nodes in patients with certain cancers03-13-13
Federal judge approves consent decree with New Jersey bakery03-13-13
FDA issues draft guidance for manufacturers to accurately label medical products that are not made with natural rubber latex03-08-13
FDA approves Osphena for postmenopausal women experiencing pain during sex02-26-13
FDA approves Stivarga for advanced gastrointestinal stromal tumors02-25-13
FDA alerts health care providers of recall of anemia drug Omontys02-24-13
FDA enters into consent decree with Chicago sprout producer due to unsanitary conditions02-22-13
FDA approves new treatment for late-stage breast cancer02-22-13
Kasel Associates Industries recalling certain pet treats due to Salmonella contamination02-21-13
FDA approves new silicone breast implant02-20-13
FDA seeks input on minimizing disruptions to medical device supply chain during extreme weather events02-20-13
U.S. Marshals seize drug products distributed by a Florida company02-14-13
FDA approves first retinal implant for adults with rare genetic eye disease02-14-13
FDA Commissioner Margaret A. Hamburg's Statement on the Institute of Medicine's Report ?Countering the Problem of Falsified and Substandard Drugs?02-13-13
FDA approves Pomalyst for advanced multiple myeloma02-08-13
Court shuts down U.S. operations of California drug, dietary supplement manufacturer02-08-13
FDA offers new guidance on developing drugs for Alzheimer's disease02-07-13
The Nutrition Facts Label: Helping Americans Make Heart-Healthy Choices02-05-13
FDA approval of generic version of cancer drug Doxil is expected to help resolve shortage02-04-13
Michigan soy processor is under court order to meet FDA food safety standards02-01-13
FDA approves new drug for the chronic management of some urea cycle disorders02-01-13
Federal judge approves consent decree with Ben Venue Laboratories01-31-13
FDA approves new orphan drug Kynamro to treat inherited cholesterol disorder01-29-13
FDA approves three new drug treatments for type 2 diabetes01-25-13
FDA: Puerto Rico beverage manufacturer enters into consent decree01-25-13
FDA approves Gleevec for children with acute lymphoblastic leukemia01-25-13
FDA approves over-the-counter Oxytrol for Women to treat overactive bladder01-25-13
FDA approves Exjade to remove excess iron in patients with genetic blood disorder01-23-13
FDA approves Botox to treat overactive bladder01-18-13
FDA approves Octaplas to treat patients with blood clotting disorders01-17-13
FDA approves new seasonal influenza vaccine made using novel technology01-16-13
FDA permits marketing of first test that can simultaneously identify 11 causes of infectious gastroenteritis01-15-13
FDA requiring lower recommended dose for certain sleep drugs containing zolpidem01-10-13
FDA issues draft guidance on abuse-deterrent opioids01-09-13
FDA proposes new food safety standards for foodborne illness prevention and produce safety01-04-13
FDA approves first anti-diarrheal drug for HIV/AIDS patients12-31-12
FDA approves first drug to treat multi-drug resistant tuberculosis12-31-12
FDA approves Eliquis to reduce the risk of stroke, blood clots in patients with non-valvular atrial fibrillation12-28-12
FDA approves new orphan drug for rare cholesterol disorder12-26-12
Federal judge enters order imposing restrictions on Sunland Inc.12-21-12
FDA approves Varizig for reducing chickenpox symptoms12-21-12
FDA expands Tamiflu's use to treat children younger than 1 year12-21-12
FDA approves Gattex to treat short bowel syndrome12-21-12
Invacare signs consent decree to correct wheelchair manufacturing problems12-20-12
FDA permits marketing of device to seal lung punctures12-19-12
FDA warns against improper advertising, promotion of lasers intended for LASIK corrective eye surgery12-18-12
FDA approves Signifor, a new orphan drug for Cushing's disease12-14-12
FDA approves raxibacumab to treat inhalational anthrax12-14-12
FDA approves Iclusig to treat two rare types of leukemia12-14-12
FDA expands Zytiga’s use for late-stage prostate cancer12-10-12
FDA warns consumers not to feed certain Nature's Deli Chicken Jerky Dog Treats12-06-12
FDA announces public-private partnership to develop regulatory science that will speed patient access to new medical device technologies12-03-12
FDA approves Cometriq to treat rare type of thyroid cancer11-29-12
FDA approves first seasonal influenza vaccine manufactured using cell culture technology11-20-12
Federal judge approves consent decree with Minnesota drug and dietary supplement company11-20-12
FDA approves pump for heart failure patients awaiting heart transplant11-20-12
FDA approves first drug-eluting stent to treat peripheral arterial disease11-15-12
FDA approves Xeljanz for rheumatoid arthritis11-06-12
FDA warns Tennessee company that online product claims violate federal law11-05-12
FDA expands use of Xarelto to treat, reduce recurrence of blood clots11-02-12
FDA reports voluntary recall of all Ameridose drug products10-31-12
FDA reports conditions observed at New England Compounding Center facility10-26-12
FDA approves Synribo for chronic myelogenous leukemia10-26-12
Federal judge grants permanent injunction against Oregon herb and supplement manufacturer10-25-12
FDA enters consent decree with New York dietary supplement manufacturer, Venus Pharmaceuticals10-25-12
Dietary supplements, unapproved drugs seized in New York10-23-12
FDA approves Fycompa to treat seizures10-22-12
FDA expands approved use of Sapien artificial heart valve10-19-12
FDA approves Jetrea for symptomatic vitreomacular adhesion in the eyes10-18-12
FDA approves Fycompa to treat seizures10-22-12
FDA expands approved use of Sapien artificial heart valve10-19-12
FDA approves Jetrea for symptomatic vitreomacular adhesion in the eyes10-18-12
FDA takes action against thousands of illegal Internet pharmacies10-04-12
FDA approves Synribo for chronic myelogenous leukemia10-26-12
Federal judge grants permanent injunction against Oregon herb and supplement manufacturer10-25-12
FDA enters consent decree with New York dietary supplement manufacturer, Venus Pharmaceuticals10-25-12
Dietary supplements, unapproved drugs seized in New York10-23-12
FDA warns Tennessee company that online product claims violate federal law11-05-12
FDA expands use of Xarelto to treat, reduce recurrence of blood clots11-02-12
FDA reports voluntary recall of all Ameridose drug products10-31-12
FDA reports conditions observed at New England Compounding Center facility10-26-12
FDA approves pump for heart failure patients awaiting heart transplant11-20-12
FDA approves first drug-eluting stent to treat peripheral arterial disease11-15-12
FDA approves Xeljanz for rheumatoid arthritis11-06-12
FDA approves Cometriq to treat rare type of thyroid cancer11-29-12
FDA approves first seasonal influenza vaccine manufactured using cell culture technology11-20-12
Federal judge approves consent decree with Minnesota drug and dietary supplement company11-20-12
FDA takes action against thousands of illegal Internet pharmacies10-04-12
FDA enters consent decree with New York dietary supplement manufacturer, Venus Pharmaceuticals10-25-12
Dietary supplements, unapproved drugs seized in New York10-23-12
FDA approves Fycompa to treat seizures10-22-12
FDA expands approved use of Sapien artificial heart valve10-19-12
FDA approves Jetrea for symptomatic vitreomacular adhesion in the eyes10-18-12
FDA reports voluntary recall of all Ameridose drug products10-31-12
FDA reports conditions observed at New England Compounding Center facility10-26-12
FDA approves Synribo for chronic myelogenous leukemia10-26-12
Federal judge grants permanent injunction against Oregon herb and supplement manufacturer10-25-12
FDA approves pump for heart failure patients awaiting heart transplant11-20-12
FDA approves first drug-eluting stent to treat peripheral arterial disease11-15-12
FDA approves Xeljanz for rheumatoid arthritis11-06-12
FDA warns Tennessee company that online product claims violate federal law11-05-12
FDA expands use of Xarelto to treat, reduce recurrence of blood clots11-02-12
FDA approves Cometriq to treat rare type of thyroid cancer11-29-12
FDA approves first seasonal influenza vaccine manufactured using cell culture technology11-20-12
Federal judge approves consent decree with Minnesota drug and dietary supplement company11-20-12
FDA takes action against thousands of illegal Internet pharmacies10-04-12
FDA approves first subcutaneous heart defibrillator09-28-12
FDA approves Humira to treat ulcerative colitis09-28-12
FDA campaign aims to protect consumers from the risks of fake online pharmacies09-28-12
FDA approves new treatment for advanced colorectal cancer09-27-12
New FDA task force will support innovation in antibacterial drug development09-24-12
FDA advises consumers not to eat Trader Joe’s Valencia Creamy Salted Peanut Butter09-22-12
FDA advises consumers not to eat Trader Joe's Valencia Creamy Salted Peanut Butter09-22-12
FDA releases preliminary data on arsenic levels in rice and rice products09-19-12
FDA issues Safety Alert on Intestinomicina, drug product marketed as treatment for infectious diarrhea09-18-12
FDA approves first breast ultrasound imaging system for dense breast tissue09-18-12
FDA warns consumers against eating mangoes from Agricola Daniella of Mexico09-14-12
FDA approves new multiple sclerosis treatment Aubagio09-12-12
FDA approves production of imaging agent that helps detect prostate cancer09-12-12
FDA issues warning letters to dietary supplement firms in Colorado and Texas for promoting unapproved products as drugs09-06-12
FDA approves new orphan drug for chronic myelogenous leukemia09-04-12
FDA approves new treatment for a type of late stage prostate cancer08-31-12
FDA approves Linzess to treat certain cases of irritable bowel syndrome and constipation08-30-12
FDA approves first drug formulated for children with rare brain tumor08-29-12
FDA approves new treatment for severe neutropenia in certain cancer patients08-29-12
FDA approves new combination pill for HIV treatment for some patients08-27-12
FDA announces recall of cantaloupe by Chamberlain Farms of Owensville Indiana08-23-12
FDA: U.S. Marshals seize food products at Fremont, Calif., warehouse08-22-12
FDA issues new safety alert on Reumofan Plus and Reumofan Plus Premium08-21-12
FDA approves first generic Actos to treat type 2 diabetes08-17-12
FDA recommends X-ray or other imaging on implanted heart defibrillators with St. Jude Medical Riata leads to help guide treatment08-16-12
FDA warns of risk of death from codeine use in some children following surgeries08-15-12
FDA approves vaccines for the 2012-2013 influenza season08-13-12
FDA approves vaccine formulation for the 2012-2013 influenza season08-13-12
FDA approves Lucentis to treat diabetic macular edema08-10-12
FDA approves Marqibo to treat rare type of leukemia08-09-12
FDA revises safety information and limits use of Stryker Wingspan brain stent system08-08-12
FDA approves first generic versions of Singulair to treat asthma, allergies08-03-12
FDA approves Zaltrap for metastatic colorectal cancer08-03-12
Food Safety Guides for Groups Most Vulnerable to Foodborne Illness Now Available08-01-12
FDA warns consumers not to eat cantaloupes from Burch Equipment LLC of North Carolina07-30-12
FDA approves Tudorza Pressair to treat chronic obstructive pulmonary disease07-23-12
FDA: More than 150 antiretroviral drugs available through PEPFAR for worldwide HIV/AIDS relief07-23-12
FDA warns consumers not to eat shellfish from Oyster Bay Harbor, Nassau County, NY07-20-12
FDA approves Afinitor for advanced breast cancer07-20-12
FDA approves Kyprolis for some patients with multiple myeloma07-20-12
FDA approves weight-management drug Qsymia07-17-12
FDA approves new colon-cleansing drug for colonoscopy prep07-17-12
FDA approves first drug for reducing the risk of sexually acquired HIV infection07-16-12
FDA seeks to halt production, distribution of dietary supplements at NY company07-13-12
FDA warns consumers about Listeria threat in Mexicali Cheese Corp. products07-13-12
FDA outlines plans to provide earlier feedback on device product submissions07-12-12
FDA, UC Davis, Agilent Technologies and CDC to create publicly available food pathogen genome database07-12-12
Wisconsin livestock dealer enters into consent decree involving drug residues in cows07-10-12
FDA approves first over-the-counter home-use rapid HIV test07-03-12
FDA introduces new safety measures for extended-release and long-acting opioid medications07-09-12
FDA approves genetic test to help some colon cancer patients, physicians considering Erbitux therapy07-06-12
FDA approves first DNA test to help manage CMV infection in organ transplant patients07-05-12
FDA prompts companies to remove certain unapproved oxycodone products from market07-05-12
FDA approves first over-the-counter home use HIV test kit07-03-12
FDA proposes unique device identification system for medical devices07-03-12
FDA approves Myrbetriq for overactive bladder06-28-12
FDA approves Belviq to treat some overweight or obese adults06-27-12
FDA allows marketing of first test to identify certain bacteria associated with bloodstream infections06-27-12
FDA approves first glaucoma stent for use with cataract surgery06-25-12
Updated FDA Statement on Compounded Versions of hydroxyprogesterone caproate (the active ingredient in Makena)06-15-12
FDA approves new combination vaccine that protects children against two bacterial diseases06-14-12
FDA urges that oysters, clams, mussels, and some types of scallops from Korea should be removed from the market06-14-12
FDA approves Perjeta for type of late-stage breast cancer06-09-12
U.S. Marshals seized misbranded drugs in Maine06-06-12
FDA warns consumers about counterfeit version of Teva's Adderall05-29-12
FDA issues alert on Reumofan Plus06-01-12
U.S. Marshals seize unapproved new drug from Crescendo Therapeutics LLC05-22-12
FDA-led research team discovers an autoimmune mechanism for serious drug-induced adverse reactions05-22-12
FDA approves generic versions of blood thinner Plavix05-17-12
FDA expands use for FilmArray Respiratory Panel05-15-12
FDA issues alert on potential dangers of unproven treatment for multiple sclerosis05-10-12
FDA proposal aims to help reduce unnecessary radiation exposure for children05-09-12
FDA issues final rule on sterility testing of biological products05-03-12
FDA permits marketing of a new device for abdominal surgery05-01-12
FDA approves new orphan drug to treat a form of Gaucher disease05-01-12
FDA approves new antibacterial treatment for plague04-30-12
FDA challenges marketing of DMAA products for lack of safety evidence04-27-12
FDA approves Stendra for erectile dysfunction04-27-12
FDA approves Votrient for advanced soft tissue sarcoma04-26-12
FDA approves Afinitor for non-cancerous kidney tumors caused by rare genetic disease04-26-12
FDA Statement on USDA Announcement of Positive BSE Test Result04-26-12
FDA strengthens international collaboration to ensure quality, safety of imported products04-23-12
Report: FDA strengthens monitoring of post-approval drug safety04-21-12
U.S. Marshals seize ultrasound gel product at a New Jersey company04-18-12
Application03-17-09
CFP Online Application--
Harry and David Issues Allergy Alert on Undeclared Peanuts in Harry & David Premium Kansas City Style Barbeque Almonds04-13-12
Availability of FDA Publications Translated into various Languages04-13-12
Food Lion Hard and Soft Taco Nutrition Label--
Food Lion Hard and Soft Taco Box--
Hannafrd Soft and Hard Taco Box--
Food Lion Yellow Taco Nutrition Label--
Food Lion Yellow Taco Box--
Hannaford Yellow Taco Nutrition Label--
Hannaford Yellow Taco Box--
Hannaford Soft and Hard Taco Nutrition Label--
Winn Dixie Taco Box--
Kroger Taco Nutrition Label--
Kroger Taco Box--
PHOTO - Mission Foods Voluntarily Recalls Taco Dinner Kits Due to Possible Undeclared Milk Allergen04-14-12
Mission Foods Voluntarily Recalls Taco Dinner Kits Due to Possible Undeclared Milk Allergen04-14-12
Winn Dixie Taco Nutrition Label--
Moon Marine USA Corporation voluntarily recalls frozen raw yellowfin tuna product “Nakaochi Scrape” associated with a multistate outbreak of Salmonella Bareilly infections04-14-12
Moon Marine USA Corporation voluntarily recalls frozen raw yellowfin tuna product04-13-12
Dept. of Justice enters consent decree with California seafood processor04-11-12
FDA takes steps to protect public health04-11-12
FDA approves imaging drug Amyvid04-10-12
FDA enters consent decree with cheese producer due to Listeria contamination04-09-12
FDA announces plans to pilot end-stage kidney disease technology in new program04-09-12
La FDA advierte a los consumidores a no comer galletas y pan tostado de marca Crispy fabricado por TWI Foods Inc., Ontario, Canadá04-09-12
FDA warns consumers not to eat Crispy brand cookies and rusk manufactured by TWI Foods Inc., Ontario, Canada04-05-12
Obama administration takes action to address tobacco epidemic03-30-12
U.S. Marshals seize unapproved and misbranded drug products at Missouri distributor03-29-12
FDA pursues enforcement action against California fish processor03-29-12
FDA to discuss risks and benefits of metal-on-metal hip replacements03-29-12
FDA approves additional blood test for viruses linked to leukemia, neurologic diseases03-27-12
FDA approves Omontys to treat anemia in adult patients on dialysis03-27-12
New FDA guidance on considerations used in device approval, de novo decisions03-27-12
FDA approves LINX Reflux Management System to treat gastroesophageal reflux disease03-22-12
FDA approves first Boniva generics to treat or prevent osteoporosis03-19-12
FDA proposes lower risk classification, guidance for certain tuberculosis tests03-16-12
FDA proposes lower risk classification for certain tuberculosis tests03-16-12
FDA approves first generic Lexapro to treat depression and anxiety disorder03-14-12
La FDA aprueba nuevos implantes de seno rellenos de gel de silicona03-10-12
FDA approves new silicone gel-filled breast implant03-09-12
FDA approves first cell-based product to treat oral mucogingival conditions in adults03-09-12
FDA Commissioner Margaret A. Hamburg's Statement on the Surgeon General's Report03-08-12
FDA approves Surfaxin to prevent breathing disorder in premature infants03-06-12
FDA issues warning letter to makers of AeroShot ?caffeine inhaler?03-06-12
FDA issues warning letter to makers of AeroShot “caffeine inhaler”03-06-12
La FDA anuncia modificaciones relacionadas con la seguridad en las indicaciones de algunos medicamentos que reducen el colesterol03-02-12
FDA approves two new pancreatic enzyme products to aid food digestion03-01-12
FDA approves first quadrivalent vaccine to prevent seasonal influenza02-29-12
FDA reaches $1 million settlement with Pennsylvania medical device firm02-28-12
FDA announces safety changes in labeling for some cholesterol-lowering drugs02-28-12
FDA approves first Helicobacter pylori breath test for children02-24-12
Federal government gains permanent injunction against raw milk producer02-22-12
FDA acts to bolster supply of critically needed cancer drugs02-21-12
FDA approves Korlym for patients with endogenous Cushing's syndrome02-17-12
FDA approves Korlym for patients with endogenous Cushing’s syndrome02-17-12
FDA approves Zioptan to treat elevated eye pressure02-14-12
FDA seeks $4.5 billion to support medical product development, protect patients and ensure safety of the food supply02-13-12
New Jersey company agrees to halt production of unapproved dental devices02-13-12
FDA investigating illegal online sale of handheld dental X-ray units02-10-12
FDA issues draft guidance on biosimilar product development02-09-12
FDA and industry reach agreement in principle on medical device user fees02-01-12
FDA approves Gleevec for expanded use in patients with rare gastrointestinal cancer01-31-12
FDA takes action against New York cheese manufacturer01-31-12
FDA approves Kalydeco to treat rare form of cystic fibrosis01-31-12
FDA approves new treatment for most common type of skin cancer01-30-12
FDA approves Inlyta to treat patients with a type of advanced kidney cancer01-27-12
Maine company holds cold smoked salmon product after FDA order01-24-12
FDA permits marketing of first test for risk of rare brain infection in some people treated with Tysabri01-20-12
FDA approves Voraxaze to treat patients with toxic methotrexate levels01-17-12
FDA to protect important class of antimicrobial drugs for treating human illness01-04-12
FDA: Chicago-area sandwich manufacturer agrees to stop production12-22-11
FDA expands use of HIV drug Isentress to children and adolescents12-21-11
FDA: Do not use ShoulderFlex Massager12-21-11
FDA collaboration to monitor rare eye condition associated with cataract surgery12-20-11
FDA approves mechanical cardiac assist device for children with heart failure12-16-11