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OC Raw Dog, LLC RECALLS Freeze Dried Sardines BECAUSE PRODUCT EXCEEDS FDA SIZE RESTRICTIONS
OC Raw Dog, LLC of Rancho Santa Margarita, CA, is recalling the Freeze Dried Sardines because the fish have exceeded the FDA compliance guideline for fish larger than 5 inches. (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 21, 2018 Category: Food Science Source Type: news

Giant Eagle Voluntarily Recalls Items Prepared with Romaine Lettuce Due to Potential E. coli Contamination
Giant Eagle, Inc. is recalling multiple items prepared with romaine lettuce and sold in its Giant Eagle, Market District and GetGo locations across western Pennsylvania, Ohio, West Virginia, Maryland and Indiana. This recall is in response to a CDC notice on romaine lettuce sourced by a supply partner from the Yuma, Arizona growing region. (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 21, 2018 Category: Food Science Source Type: news

FDA authorizes new use of test, first to identify the emerging pathogen < i > Candida auris < /i >
FDA authorized the first test to identify the emerging pathogen Candida auris, which can cause serious infections in hospitalized patients. (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 20, 2018 Category: American Health Source Type: news

FDA Approves First Drug for Rare Form of Rickets
FRIDAY, April 20, 2018 -- Ultragenyx Pharmaceutical Inc.'s Crysvita (burosumab-twza) has been approved by the U.S. Food and Drug Administration to treat adults and children ages 1 year and older with x-linked hypophosphatemia (XLH). A clinical trial... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - April 20, 2018 Category: Pharmaceuticals Source Type: news

FDA Staff Raises Safety Concerns Over Lilly/Incyte Arthritis Drug FDA Staff Raises Safety Concerns Over Lilly/Incyte Arthritis Drug
An experimental rheumatoid arthritis drug developed by Eli Lilly and Co and Incyte Corp poses serious risks of deadly blood clots at higher doses, U.S. Food and Drug Administration staff said on Thursday, the latest setback to a treatment regulators declined to approve last year.Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - April 20, 2018 Category: Consumer Health News Tags: Medscape Today News Source Type: news

Helsinn Group announces the FDA approval of the IV formulation of AKYNZEO(R) (fosnetupitant/ palonosetron) in the United States
Lugano, Switzerland April 20, 2018 - Helsinn, a Swiss pharmaceutical group focused on building quality cancer care products, today announces that the U.S. Food and Drug Administration (FDA) has approved the intravenous formulation of AKYNZEO® (NEPA, a ... Biopharmaceuticals, Oncology, FDA Helsinn Group, AKYNZEO, fosnetupitant, palonosetron, antiemetic (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - April 20, 2018 Category: Pharmaceuticals Source Type: news

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to encourage more widespread innovation and development of new treatments for opioid use disorder
FDA announces new steps to encourage more widespread innovation and development of new treatments for opioid use disorder (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 20, 2018 Category: American Health Source Type: news

FDA takes new steps to advance the development of innovative products for treating opioid use disorder
FDA announces new steps to encourage and support the development of treatment options for people with opioid use disorder (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 20, 2018 Category: American Health Source Type: news

Eataly USA Issues Allergy Alert on Undeclared Walnuts in Artichoke Spread
Eataly USA of New York City, New York is recalling Eataly Artichoke Spread, because it may contain undeclared walnuts. People who have an allergy or severe sensitivity to walnuts run the risk of serious or life-threatening allergic reaction if they consume these products. (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 20, 2018 Category: Food Science Source Type: news

Rodents and filth linked to egg recall by FDA
An inspection report released Thursday by the US Food and Drug Administration indicates that the North Carolina farm linked to a multistate outbreak of Salmonella from contaminated eggs had an ongoing rodent infestation, unsanitary conditions and poor employee practices. (Source: CNN.com - Health)
Source: CNN.com - Health - April 19, 2018 Category: Consumer Health News Source Type: news

Federal judge enters consent decree against Cantrell Drug Company
Cantrell Drug Company prohibited from manufacturing and distributing sterile drug products in violation of the law (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 19, 2018 Category: American Health Source Type: news

Rodents and filth cited in FDA report on farm linked to egg recall
An inspection report released Thursday by the US Food and Drug Administration indicates that the North Carolina farm linked to a multistate outbreak of Salmonella from contaminated eggs had an ongoing rodent infestation, unsanitary conditions and poor employee practices. (Source: CNN.com - Health)
Source: CNN.com - Health - April 19, 2018 Category: Consumer Health News Source Type: news

F.D.A. Panel Recommends Approval of Cannabis-Based Drug for Epilepsy
Epidiolex was developed to treat two rare and devastating forms of the disease. It contains a chemical compound found in marijuana but not the one that makes people high. (Source: NYT Health)
Source: NYT Health - April 19, 2018 Category: Consumer Health News Authors: SHEILA KAPLAN Tags: Marijuana Food and Drug Administration Epilepsy Seizures (Medical) Drugs (Pharmaceuticals) Epidiolex GW Pharmaceuticals Source Type: news

Canada Says Working With U.S. FDA to Address EpiPen Shortage Canada Says Working With U.S. FDA to Address EpiPen Shortage
Canada's government health agency said on Tuesday it is working with the U.S. Food and Drug Administration to address a shortage of Mylan N.V.'s EpiPen emergency allergy antidote that has hit several countries outside of the United States, where it is manufactured.Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - April 19, 2018 Category: Consumer Health News Tags: Medscape Today News Source Type: news

GW Pharma gets FDA panel nod, first cannabis-based drug nearing approval
(Reuters) - An advisory panel to the U.S. Food and Drug Administration on Thursday unanimously voted in favor of approving the first cannabis-derived medicine in the country, a childhood epilepsy treatment developed by GW Pharma. (Source: Reuters: Health)
Source: Reuters: Health - April 19, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

First marijuana-derived drug poised for FDA approval after winning support from advisers
Food and Drug Administration advisers on Thursday unanimously supported the first-ever government approval of a medication made from cannabis, paving the way for agency clearance by the end of June. The drug, Epidiolex, would be administered in a syrup form and is made from a purified ingredient in cannabis called cannabidiol, or CBD. It is […]Related:New CDC chief stepped down from four groups to comply with ethics rulesThese are the top priorities for the nation’s top cancer doctorFor advanced lung cancer, immune therapy plus chemo prolongs survival (Source: Washington Post: To Your Health)
Source: Washington Post: To Your Health - April 19, 2018 Category: Consumer Health News Source Type: news

Marijuana-derived drug for epilepsy gets FDA committee recommendation
A US Food and Drug Administration advisory committee on Thursday unanimously recommended approval of an epilepsy drug that would be the first plant-derived cannabidiol medicine for prescription use in the United States. (Source: CNN.com - Health)
Source: CNN.com - Health - April 19, 2018 Category: Consumer Health News Source Type: news

Marijuana-derived drug for epilepsy gets FDA recommendation
A US Food and Drug Administration advisory committee on Thursday unanimously recommended approval of an epilepsy drug that would be the first plant-derived cannabidiol medicine for prescription use in the United States. (Source: CNN.com - Health)
Source: CNN.com - Health - April 19, 2018 Category: Consumer Health News Source Type: news

Superior Foods Company Voluntarily Recalls 487 lbs. of Smoked Salmon Spreads
Superior Foods Company located in Kentwood, Michigan is voluntarily recalling a specific lot of Smoked Salmon Spreads (487 lbs.) that were produced on March 26, 2018. This voluntary action is being undertaken in cooperation with the U.S. Food and Drug Administration and the Michigan Department of Agriculture and Rural Development. (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 19, 2018 Category: Food Science Source Type: news

Spending on medicines grew less than one percent in 2017
Last year, a record number of new treatments and cures that are transforming care for patients fighting debilitating diseases like cancer, hepatitis C, high cholesterol and more were approved by the U.S. Food and Drug Administration. In the midst of all this incredible progress, spending on medicines grewjust 0.6 percent in 2017, according to the newIQVIA Institute for Human Data Science “2017 Medicine Use and Spending in the U.S.” report. (Source: The Catalyst)
Source: The Catalyst - April 19, 2018 Category: Pharmaceuticals Tags: FDA cancer drug cost Hepatitis C high cholesterol Biologics and Biosimilars Source Type: news

NGB Corp. Recalls NxtGen Botanicals Maeng Da Kratom Because of Possible < em > Salmonella < /em > Contamination
NGB Corp. of West Jordan, Utah is voluntarily recalling NxtGen Botanicals Maeng Da Kratom labeled bottles of encapsulated product because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 19, 2018 Category: Food Science Source Type: news

FDA clears Icometrix's dementia diagnosis software
The U.S. Food and Drug Administration (FDA) has cleared software developer...Read more on AuntMinnie.comRelated Reading: Icometrix announces launch of TBI commission FDA clears Icometrix's image quantification software (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - April 19, 2018 Category: Radiology Source Type: news

FDA panel unanimously backs GW Pharma's cannabis-based epilepsy drug
(Reuters) - GW Pharmaceuticals Plc's cannabis-derived drug to treat a severe form of childhood epilepsy was unanimously backed on Thursday by an advisory panel to the U.S. Food and Drug Administration. (Source: Reuters: Health)
Source: Reuters: Health - April 19, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

FDA panel unanimously votes for GW Pharma's cannabis-derived epilepsy drug
(Reuters) - GW Pharmaceuticals Plc's cannabis-based drug to treat a severe form of childhood epilepsy was unanimously backed on Thursday by an advisory panel to the U.S. Food and Drug Administration. (Source: Reuters: Health)
Source: Reuters: Health - April 19, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

FDA staff raises safety concerns over Lilly/Incyte arthritis drug
(Reuters) - U.S. Food and Drug Administration staff flagged concerns on Thursday about potentially fatal blood clots from higher doses of a rheumatoid arthritis drug developed by Eli Lilly and Co and Incyte Corp, a fresh setback after regulators declined to approve the treatment last year. (Source: Reuters: Health)
Source: Reuters: Health - April 19, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

Viable Solutions, LLC Recalls Certain Kratom-Containing Powder Products Because of Possible Health Risk
Viable Solutions of Nampa, ID has initiated a recall of certain Kratom-containing powder products, because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 19, 2018 Category: Food Science Source Type: news

AstraZeneca wins U.S. FDA approval for first-line use of lung cancer drug
(Reuters) - AstraZeneca Plc said on Wednesday the U.S. Food and Drug Administration (FDA) has approved the 1st-line use of its lung cancer drug, Tagrisso. (Source: Reuters: Health)
Source: Reuters: Health - April 19, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

TruPet LLC Recalls Boost Me Mighty Meaty Beef Topper Meal Enhancer Because of Possible < em > Salmonella < /em > Contamination
TruPet, LLC of Milford, OH, is voluntarily recalling a limited amount of Boost Me Mighty Meaty Beef Topper Meal Enhancer because the products have the potential to be contaminated with Salmonella. The recall is limited to 400 cases of the product, as identified below. (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 18, 2018 Category: Food Science Source Type: news

Siemens receives FDA OK for CT scanners
Siemens Healthineers has received clearance from the U.S. Food and Drug Administration...Read more on AuntMinnie.comRelated Reading: Siemens secures clearance for updated Somatom Force CT Siemens nets FDA clearance for Edge Plus CT scanner Siemens lands FDA clearance for Mammomat Revelation Siemens Healthineers launches IPO, raising $5.2B Siemens to debut portable cardiovascular US at ACC 2018 (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - April 18, 2018 Category: Radiology Source Type: news

Is Sushi Healthy? Here ’s Everything You Need to Know
Americans eat sushi in venues as varied as high-end restaurants and prepared foods sections of grocery stores — and many believe it’s a nutritious choice. But is sushi healthy? “Sushi has this halo of being healthy,” says Katherine Zeratsky, a registered dietitian nutritionist and associate professor of nutrition at Mayo Clinic. After all, traditional sushi has all the makings of a health food: it’s stuffed with fresh fish, wrapped in thin sheets of seaweed and presented in neat little rolls. But experts warn not to expect your weekly spicy tuna order to slim your waistline. One of the biggest...
Source: TIME: Health - April 18, 2018 Category: Consumer Health News Authors: Sophia Gottfried Tags: Uncategorized Diet/Nutrition healthytime Source Type: news

Amazon insists its food warehouses are EXEMPT from FDA food safety rules
(Natural News) Food safety laws are a very important part of consumer and public health. Food safety enforcement ensures that spoiled, outdated products aren’t consumed. These laws help safeguard against bio-terrorism, food borne illnesses, fungus, mold, and infectious bacteria. A Kentucky food warehouse owned by Amazon is not registered with the Food and Drug Administration.... (Source: NaturalNews.com)
Source: NaturalNews.com - April 18, 2018 Category: Consumer Health News Source Type: news

Carnivore Meat Company Issues Voluntary Recall of limited batches of “Vital Essentials® Freeze-Dried Beef Toppers” and “Vital Essentials® Frozen Beef Chub Entrée for Dogs” Pet Food
Carnivore Meat Company of Green Bay, WI, is voluntarily recalling a limited amount of pet food because the products may have the potential to be contaminated with Salmonella. (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 18, 2018 Category: Food Science Source Type: news

Carnivore Meat Company Issues Voluntary Recall of limited batches of “ Vital Essentials ® Freeze-Dried Beef Toppers ” and “ Vital Essentials ® Frozen Beef Chub Entr é e for Dogs ” Pet Food
Carnivore Meat Company of Green Bay, WI, is voluntarily recalling a limited amount of pet food because the products may have the potential to be contaminated with Salmonella. (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 18, 2018 Category: Food Science Source Type: news

Triangle Pharmataturals Recalls Kratom Products Due to Potential Salmonella Contamination
Triangle Pharmanaturals, LLC ( “Triangle”) of Las Vegas, Nevada is recalling all kratom (mitragyna speciosa) powder products it manufactured, processed, packed, and/or held, between April 4, 2017 to Present. Specifically, such products include: (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 17, 2018 Category: Food Science Source Type: news

Canada seeks U.S. help to solve EpiPen shortage
TORONTO (Reuters) - Canada said on Tuesday it is working with the U.S. Food and Drug Administration to access supplies of Mylan N.V.'s EpiPen emergency allergy antidote amid a global shortage that has spared the United States. (Source: Reuters: Health)
Source: Reuters: Health - April 17, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

FDA Approves First Contact Lens That Gets Darker In Sunlight
CBS Local — The U.S. Food and Drug Administration has approved a new invention that may make wearing sunglasses a thing of the past. FDA officials signed off on the first ever transition contact lenses, which will get darker when the wearer is out in sunlight. “This contact lens is the first of its kind to incorporate the same technology that is used in eyeglasses that automatically darken in the sun,” the FDA’s Malvina Eydelman said in a press release. The agency tested the new lenses on 24 patients to make sure there were no problems with driving during the day and at night. None of the users repo...
Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire - April 17, 2018 Category: Consumer Health News Authors: Health – CBS Boston Tags: Health News Chris Melore Contact Lenses FDA Local TV Sunglasses talkers Source Type: news

FDA Approves Crysvita (burosumab-twza) for X-Linked Hypophosphatemia
April 17, 2018 -- The U.S. Food and Drug Administration today approved Crysvita (burosumab), the first drug approved to treat adults and children ages 1 year and older with x-linked hypophosphatemia (XLH), a rare, inherited form of rickets. XLH... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 17, 2018 Category: Drugs & Pharmacology Source Type: news

Trace-Ability nets FDA OK for PET tracer device
Trace-Ability has received approval from the U.S. Food and Drug Administration...Read more on AuntMinnie.com (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - April 17, 2018 Category: Radiology Source Type: news

Canada says working with FDA to address EpiPen shortage
TORONTO (Reuters) - Canada's government health agency said on Tuesday it is working with the U.S. Food and Drug Administration to address a shortage of Mylan N.V.'s EpiPen emergency allergy antidote that has hit several countries outside of the United States, where it is manufactured. (Source: Reuters: Health)
Source: Reuters: Health - April 17, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

FDA approves Opdivo, Yervoy combination for kidney cancer
The Food and Drug Administration has approved a combination of two immunotherapy drugs, ipilimumab and nivolumab, to treat metastatic kidney cancer. (Source: Health News - UPI.com)
Source: Health News - UPI.com - April 17, 2018 Category: Consumer Health News Source Type: news

Remarks from FDA Commissioner Scott Gottlieb, M.D. on Fiscal Year 2019 budget request for FDA
FDA Commissioner Scott Gottlieb, M.D. remarks to the U.S. House Committee on Appropriations on the FDA ’s Fiscal Year 2019 budget (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 17, 2018 Category: American Health Source Type: news

FDA approves Rigel Pharmaceuticals' drug for rare bleeding disorder
(Reuters) - The U.S. Food and Drug Administration on Tuesday approved Rigel Pharmaceuticals Inc's treatment for a rare bleeding disorder. (Source: Reuters: Health)
Source: Reuters: Health - April 17, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

FDA approves Ultragenyx's drug for rare form of rickets
(Reuters) - The U.S. Food and Drug Administration has approved Ultragenyx Pharmaceutical Inc's treatment for a rare and inherited form of rickets, a condition that causes weak bones, the agency said on Tuesday. (Source: Reuters: Health)
Source: Reuters: Health - April 17, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

FDA approves first therapy for rare inherited form of rickets, x-linked hypophosphatemia
FDA approved Crysvita (burosumab), the first drug approved to treat adults and children ages 1 year and older with x-linked hypophosphatemia (XLH), a rare form of rickets. (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 17, 2018 Category: American Health Source Type: news

Statement by Dr. Susan Mayne on FDA efforts to reduce consumer exposure to arsenic in rice
One way FDA oversees food safety is through monitoring of contaminants in food, such as arsenic, assessing potential exposure and taking steps to reduce exposure (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 17, 2018 Category: American Health Source Type: news

Report: China to restructure its FDA
China is looking to restructure its Food and Drug Administration, according to a new report from the Regulatory Affairs Professionals Society. With the reorganization, the CFDA will cease being a standalone department and will become part of the country’s National Market Supervision Association, according to the report. The CFDA group is slated to add an additional 100 new individuals focused on regulating devices, and will drop its oversight of food, according to the report. The CFDA will also pursue increased inspections of foreign entities and penalties for noncompliance. “​Previously, the registration of ...
Source: Mass Device - April 17, 2018 Category: Medical Devices Authors: Fink Densford Tags: Regulatory/Compliance China Food & Drug Administration (CFDA) Source Type: news

World ’ s Best Cheese Recalls l ’ Explorateur Soft Ripened Cheese Due to Possible Health Risk
World ’ s Best Cheeses of Armonk, NY is recalling 22 cases of Formagerie de la Brie brand, l ’ Explorateur soft ripened cheese because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 17, 2018 Category: Food Science Source Type: news

Marijuana-Based Medicine To Reduce Seizures Gets Positive FDA Review
WASHINGTON (AP) — A closely watched medicine made from the marijuana plant reduces seizures in children with severe forms of epilepsy and warrants approval in the United States, health officials said Tuesday. British drugmaker GW Pharmaceuticals is seeking permission to sell its purified form of an ingredient found in cannabis — one that doesn’t get users high — as a medication for rare, hard-to-treat seizures in children. If successful, the company’s liquid formula would be the first government-approved drug derived from the cannabis plant in the U.S. The Food and Drug Administration’s ...
Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire - April 17, 2018 Category: Consumer Health News Authors: Health – CBS Boston Tags: Boston News Health Cannabidiol Epidiolex Local TV Marijuana Oil Source Type: news

Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to enhance and modernize the FDA ’s approach to medical device safety and innovation
The FDA is releasing the Medical Device Safety Action Plan that outlines our vision for how FDA can continue to enhance our programs and processes to assure the safety of medical devices (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 17, 2018 Category: American Health Source Type: news

GW cannabis-derived epilepsy drug gets positive FDA staff review
LONDON (Reuters) - GW Pharmaceuticals' cannabis-derived medicine for severe childhood epilepsy won a favorable review from U.S. Food and Drug Administration (FDA) staff on Tuesday, boosting hopes for its approval in the world's biggest drugs market. (Source: Reuters: Health)
Source: Reuters: Health - April 17, 2018 Category: Consumer Health News Tags: healthNews Source Type: news