Sanofi drug Dupixent wins FDA approval to treat asthma
France's Sanofi SA said on Friday eczema drug Dupixent was approved by the U.S. Food and Drug Administration as an additional maintenance therapy in patients with two types of asthma. (Source: Reuters: Health)
Source: Reuters: Health - October 19, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

Working Cow Homemade, Inc. Expands Recall of Ice Cream Products Because of Possible Health Risk
Working Cow Homemade, Inc. of St. Petersburg, FL is expanding its voluntary recall to include all ice cream manufactured from August 29, 2017 – October 11, 2018, 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 shor t-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. Th...
Source: Food and Drug Administration - October 19, 2018 Category: Food Science Source Type: news

Cedar ’s Mediterranean Foods Issues Allergy Alert on Undeclared Soy in Cedar’s Chickpea Salad 8 oz.
Cedar ’s Mediterranean Foods, of Ward Hill, MA is voluntarily recalling Cedar’s Chickpea Salad 8 oz. because it may contain undeclared edamame (soy). People who have an allergy or severe sensitivity to soy 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 - October 19, 2018 Category: Food Science Source Type: news

Weekly Postings
See something of interest? Please share our postings with colleagues in your institutions! Spotlight The MAReport: read the Summer/Fall 2018 issue of the MAReport newsletter! This quarter, Health Professions Coordinator Erin Seger wrote about her experiences at the 17th annual Philadelphia Trans Wellness Conference, and LGBT health information needs in her article, “LGBT Health Information Resources.” Member Highlights: Stony Brook University, Southampton, NY – learn about how the Applied Health Informatics Program at Stony Brook used NNLM MAR funding to conduct a Wellness Fair for seniors, and later...
Source: NN/LM Middle Atlantic Region Blog - October 19, 2018 Category: Databases & Libraries Authors: Hannah Sinemus Tags: Weekly Postings Source Type: news

FDA approves label update for Roche ’s Mabthera/Rituxan (rituximab) in two rare forms of vasculitis
Roche announced today that the U.S. Food and Drug Administration (FDA) has approved an update to the MabThera/Rituxan ® (rituximab) label to include information on follow up treatment of adult patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) who have achieved disease control with induction treatment. (Source: Roche Investor Update)
Source: Roche Investor Update - October 19, 2018 Category: Pharmaceuticals Source Type: news

Statement by FDA Commissioner Scott Gottlieb, M.D., on FDA ’s new steps to help produce farmers, processors more effectively comply with food safety requirements
Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA ’s new steps to help produce farmers, fresh-cut produce processors more effectively comply with food safety requirements (Source: Food and Drug Administration)
Source: Food and Drug Administration - October 19, 2018 Category: American Health Source Type: news

FDA launches pilot to expand special 510(k) market pathway
By Stewart Eisenhart, Emergo Group Medical device regulators at the US Food and Drug Administration has initiated a new pilot program for expanded eligibility in the agency’s Special 510(k) pathway, potentially easing market compliance requirements for more manufacturers whose devices have undergone modifications. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees. The post FDA launches pilot to expand special 510(k) market pathway appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - October 19, 2018 Category: Medical Devices Authors: Danielle Kirsh Tags: Blog Emergo Group Source Type: news

Hy-Vee Voluntarily Recalls Several Meat and Potato Products
Hy-Vee, Inc., based in West Des Moines, Iowa, is voluntarily recalling six of its meat and potato products across its eight-state region due to possible contamination with Salmonella and Listeria monocytogenes. The potential for contamination was discovered after Hy-Vee ’s supplier, McCain Foods, announced it was recalling its caramelized mushrooms and fire-roasted tomatoes, which are ingredients that are used in six Hy-Vee products. To date, no illnesses have been reported in connection with these products. (Source: Food and Drug Administration)
Source: Food and Drug Administration - October 19, 2018 Category: Food Science Source Type: news

$5.1 million grant will fund research to develop stem cell-based therapy for blinding eye conditions
Scientists at the UCLA  Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research and the Stein Eye Institute have been awarded a $5.1 million grant from the California Institute for Regenerative Medicine to advance the development of a novel therapy for blinding retinal conditions.The award by the California Institute for Regenerative Medicine, or CIRM, will support the development of a treatment that will use patients ’ own skin cells to generate autologous induced pluripotent stem cells to derive retinal pigment epithelium cells, which are lost in many blinding eye conditions....
Source: UCLA Newsroom: Health Sciences - October 19, 2018 Category: Universities & Medical Training Source Type: news

FDA seeks to amend MQSA mammography regulations
The U.S. Food and Drug Administration (FDA) has submitted a proposed rule to...Read more on AuntMinnie.comRelated Reading: FDA, DHS ramp up cooperation on cybersecurity FDA proposes update to cybersecurity guidance FDA restores Fla. mammography center's accreditation FDA to work with tech on digital health innovation C-MIMI: FDA readies program to speed software reviews (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - October 18, 2018 Category: Radiology Source Type: news

Trump Administration Launches “Winning on Reducing Food Waste” Initiative
The U.S. Department of Agriculture (USDA), the U.S. Environmental Protection Agency (EPA), and the U.S. Food and Drug Administration (FDA) today announced the signing of a joint agency formal agreement under the " Winning on Reducing Food Waste " initiative. (Source: Food and Drug Administration)
Source: Food and Drug Administration - October 18, 2018 Category: American Health Source Type: news

Stewart ’s Shops Issues Allergy Alert on Undeclared Milk in Cranberry Apple Refresher
Saratoga Springs, NY - Stewart ’s Shops Corp. is recalling units of Stewart’s Shops brand Cranberry Apple Refresher 16 fluid oz. because the product may contain undeclared milk. People who have an allergy to milk run the risk of serious or life-threatening allergic reaction if they consume this product. Approximately 2,300 u nits of affected product were distributed in upstate New York and Southern Vermont. (Source: Food and Drug Administration)
Source: Food and Drug Administration - October 18, 2018 Category: Food Science Source Type: news

FDA snubs Novartis bid to repurpose inflammation drug for heart attacks
The U.S. Food and Drug Administration has rejected Novartis's bid to repurpose a drug now approved for rare inflammatory diseases to be used in a group of heart attack survivors, the Swiss drugmaker said on Thursday. (Source: Reuters: Health)
Source: Reuters: Health - October 18, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

US FDA grants Lynparza Orphan Drug Designation for pancreatic cancer
AstraZeneca and Merck & Co., Inc., Kenilworth, N.J., US (Merck: known as MSD outside the US and Canada) announced that they were granted orphan drug designation (ODD) by the US Food and Drug Administration (FDA) for Lynparza (olaparib) for the treatment of pancreatic cancer. (Source: World Pharma News)
Source: World Pharma News - October 18, 2018 Category: Pharmaceuticals Tags: Featured AstraZeneca Business and Industry Source Type: news

P. East Trading Corp. Issues Alert on Undeclared Sulfites In Fruits Du Sud Golden Seedless Raisins
P. EAST TRADING CORP. of Bronx, NY is recalling Fruits Du Sud Golden Seedless Raisins (Lot No. FDS T499/18) 30 lbs Box, because they contain undeclared SULFITES. People who have a severe sensitivity to sulfites run the risk of serious or life-threatening reactions if they consume these products. (Source: Food and Drug Administration)
Source: Food and Drug Administration - October 17, 2018 Category: Food Science Source Type: news

SLR Food Distribution Inc. Issues Alert on Undeclared Sulfites in Sugar Melon Candy
SLR Food Distribution Inc. of New Hyde Park, NY is recalling its 7.04oz package of SUGAR MELON CANDY / WAX GOURD because it contains undeclared sulfites. Consumers who have severe sensitivity to sulfites run the risk of serious or life-threatening allergic reactions if they consume this product. (Source: Food and Drug Administration)
Source: Food and Drug Administration - October 17, 2018 Category: Food Science Source Type: news

New Nan Fong Hong Trading Inc. Issues Allergy Alert on Undeclared Sulfites in Source Day Natural Treasures Dried Liquorice Slice
New Nan Fong Hong Trading Inc. is recalling its 16 oz (454g) packages of Source Day Natural Treasures Dried Liquorice Slice because they contain undeclared sulfites. Consumers who are allergic to sulfite allergens run the risk of serious or life-threatening allergic reactions if they consume this product. (Source: Food and Drug Administration)
Source: Food and Drug Administration - October 17, 2018 Category: Food Science Source Type: news

FDA proposes update to cybersecurity guidance
The U.S. Food and Drug Administration (FDA) has released a proposal to strengthen...Read more on AuntMinnie.comRelated Reading: FDA, DHS ramp up cooperation on cybersecurity FDA to work with tech on digital health innovation C-MIMI: FDA readies program to speed software reviews MITA hails FDA quality report, seeks legislative action Cybersecurity threats pose challenge to radiology's future (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - October 17, 2018 Category: Radiology Source Type: news

Faribault Foods, Inc. Announces Voluntary Recall of a Limited Quantity of S & W Brand White Beans Due to the Presence of Undeclared (Sulfites)
Faribault Foods, Inc. of Faribault, MN is recalling its 15 ounce S&W White Beans because it contains undeclared sulfites. People who have an allergy or severe sensitivity to sulfites run the risk of serious or life-threatening allergic reaction if they consume this product. (Source: Food and Drug Administration)
Source: Food and Drug Administration - October 17, 2018 Category: Food Science Source Type: news

FDA seeks to strengthen cybersecurity of medical devices
The Food and Drug Administration is working with the Department of Homeland Security for better coordination of the cybersecurity of medical devices. (Source: Health News - UPI.com)
Source: Health News - UPI.com - October 17, 2018 Category: Consumer Health News Source Type: news

FDA, DHS ramp up cooperation on cybersecurity
The U.S. Food and Drug Administration (FDA) and the U.S. Department of Homeland...Read more on AuntMinnie.comRelated Reading: FDA to work with tech on digital health innovation C-MIMI: FDA readies program to speed software reviews MITA hails FDA quality report, seeks legislative action Cybersecurity threats pose challenge to radiology's future Cybersecurity remains a problem in radiology (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - October 17, 2018 Category: Radiology Source Type: news

FDA Approves Talzenna (talazoparib) for gBRCAm HER2-Negative Locally Advanced or Metastatic Breast Cancer
On October 16, 2018, the Food and Drug Administration approved talazoparib (Talzenna, Pfizer Inc.), a poly (ADP-ribose) polymerase (PARP) inhibitor, for patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm),... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 16, 2018 Category: Drugs & Pharmacology Source Type: news

Clackamas Bakery Recalls Fred Meyer Bakery Angel Food Cake Bar Due to Undeclared Allergens
Clackamas Bakery has recalled Fred Meyer Bakery Angel Food Cake Bar (12 oz.) sold in its retail stores because the product may contain milk and soy not listed on the label. Clackamas Bakery initiated the recall when it was discovered that the Fred Meyer Bakery Angel Food Cake Bar label had been incorrectly applied to packages of cornbread. (Source: Food and Drug Administration)
Source: Food and Drug Administration - October 16, 2018 Category: Food Science Source Type: news

FDA and DHS increase coordination of responses to medical device cybersecurity threats under new partnership; a part of the two agencies ’ broader effort to protect patient safety
FDA and DHS announce partnership to address medical device cybersecurity threats (Source: Food and Drug Administration)
Source: Food and Drug Administration - October 16, 2018 Category: American Health Source Type: news

HHS Launches Review of Fetal Tissue Research
The Department of Health and Human Services (HHS) issued a statement on September 24, 2018 announcing that it has launched a review of all research and acquisitions involving human fetal tissue. The agency, which funds through the National Institutes of Health a significant portion of U.S. biomedical research, indicated that it will look into adequate alternatives to the use of human fetal tissue in HHS funded research and will ensure that efforts to develop such alternatives are funded. According to the statement, “HHS has initiated a comprehensive review of all research involving fetal tissue to ensure consistency...
Source: Public Policy Reports - October 16, 2018 Category: Biology Authors: AIBS Source Type: news

FDA approves Pfizer's drug for advanced breast cancer
The U.S. Food and Drug Administration said on Tuesday it approved Pfizer Inc's drug for an advanced form of breast cancer tied to an inherited gene mutation. (Source: Reuters: Health)
Source: Reuters: Health - October 16, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

FDA needs best and brightest to advance a new era of medicine with America ’s biopharmaceutical companies
The U.S Food and Drug Administration (FDA) plays a critical role in protecting and promoting the health of all Americans. Every day, the FDA does important work to ensure the safety, efficacy and security of our nation ’s medical products, including human drugs and biologics. From reviewing the drug profile of a first-in-class medicine up for approval, to inspecting a medicine’s manufacturing site, the FDA’s experts engage in a range of regulatory review activities intended to bring safe and effective new me dicines to patients in a timely manner. In the past year alone, the FDA approved a record number o...
Source: The Catalyst - October 16, 2018 Category: Pharmaceuticals Authors: Richard Moscicki, M.D. Tags: FDA PDUFA Source Type: news

FDA approves Pfizer's breast cancer drug
The U.S. Food and Drug Administration said on Tuesday it approved Pfizer Inc's drug for advanced form of breast cancer. (Source: Reuters: Health)
Source: Reuters: Health - October 16, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

$65 million: Aclaris buying rights to rosacea drug from Allergan
Aclaris Therapeutics has entered into a definitive agreement to acquire the worldwide rights to Rhofade cream, a rosacea treatment, from Allergan for $65 million. Rhofade was approved by the Food and Drug Administration in January 2017 for the topical treatment of persistent facial erythema, or redness, associated with rosacea in adults. The skin disorder afflicts an estimated 16 million people in the United States, according to the National Rosacea Society . “We are excited to acquire Rhofade;… (Source: bizjournals.com Health Care News Headlines)
Source: bizjournals.com Health Care News Headlines - October 16, 2018 Category: Health Management Authors: John George Source Type: news

U.S. regulators to overhaul third-party 510(k) review program
By Stewart Eisenhart, Emergo Group The US Food and Drug Administration has set a goal of obviating the need to re-review 85% or more of 510(k) applications that have undergone third-party review by the agency’s 2021 fiscal year. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees. The post U.S. regulators to overhaul third-party 510(k) review program appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - October 16, 2018 Category: Medical Devices Authors: Danielle Kirsh Tags: Blog Emergo Group Source Type: news

Feel Good Foods Inc Issues Allergy Alert on Undeclared Egg Product In “Vegetable Fried Rice”
Feel Good Foods Inc. of Brooklyn, NY is recalling six lots of “Vegetable Fried Rice” frozen meals, UPC 00899039002129 because they may contain undeclared egg. People who have allergies to egg 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 - October 16, 2018 Category: Food Science Source Type: news

Fat Burners Zone Issues Voluntary Nationwide Recall of Zero Xtreme Due to Presence of Undeclared Sibutramine
Fat Burners Zone is voluntarily recalling 1 lot of Zero Xtreme, capsules to the consumer level. FDA analysis has found Zero Xtreme to be tainted with sibutramine. Sibutramine is an appetite suppressant that was withdrawn from the U.S. market due to safety concerns. The presence of Sibutramine in Zero Xtreme renders it an unapproved drug for which safety and efficacy has not been established and, therefore, subject to recall. (Source: Food and Drug Administration)
Source: Food and Drug Administration - October 15, 2018 Category: Food Science Source Type: news

Apollo Food International Inc Issues Allergy Alert on Undeclared Eggs In “Mini Roll”
Apollo Food International Inc. of Long Island City, NY, is recalling its 2.469 ounce packages of “Mini Roll” food treats because they may contain undeclared eggs. Consumers who are allergic to eggs may run the risk of serious or life-threatening allergic reactions if they consume this product. (Source: Food and Drug Administration)
Source: Food and Drug Administration - October 15, 2018 Category: Food Science Source Type: news

Statement by FDA Commissioner Scott Gottlieb, M.D., on FDA ’s new steps to modernize drug development, improve efficiency and promote innovation of targeted therapies
FDA issues two guidance documents to provide drug developers greater clarity and direction as they pursue the next generation of therapies and treatments for patients. (Source: Food and Drug Administration)
Source: Food and Drug Administration - October 15, 2018 Category: American Health Source Type: news

Statement by FDA Commissioner Scott Gottlieb, M.D., on FDA ’ s new steps to modernize drug development, improve efficiency and promote innovation of targeted therapies
FDA issues two guidance documents to provide drug developers greater clarity and direction as they pursue the next generation of therapies and treatments for patients. (Source: Food and Drug Administration)
Source: Food and Drug Administration - October 15, 2018 Category: American Health Source Type: news

Active Pharmaceuticals ID'd in & #62;700 Dietary Supplements
MONDAY, Oct. 15, 2018 -- Dietary supplements often include active pharmaceuticals, even after warnings from the U.S. Food and Drug Administration, according to a study published online Oct. 12 in JAMA Network Open. Jenna Tucker, M.P.H., from the... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - October 15, 2018 Category: Pharmaceuticals Source Type: news

Health Tip: Protect Your Food From Hurricane Threats
-- Lengthy power outages are often unwanted headaches left in the wake of hurricanes and other severe storms. The U.S. Food and Drug Administration offers the following ways to prepare for unpredictable weather by having key supplies... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - October 15, 2018 Category: General Medicine Source Type: news

Study shows children are still being prescribed opioid pain relievers despite federal warnings against the practice
(Natural News) A new study shows that at least one in 20 children are still receiving codeine for pain management following tonsil and adenoid removal procedures, three years after the Food and Drug Administration (FDA) had restricted its use on kids. The team, composed of members from the University of Chicago Medicine, the University of Michigan, and Harvard... (Source: NaturalNews.com)
Source: NaturalNews.com - October 14, 2018 Category: Consumer Health News Source Type: news

Stop vaping Viagra: FDA cracks down on company selling e-liquid for erectile dysfunction in America
The US Food and Drug Administration issued a warning letter to HelloCig Electronic Tech Company on Thursday for selling two e-liquids that contain the erectile dysfunction drug. (Source: the Mail online | Health)
Source: the Mail online | Health - October 12, 2018 Category: Consumer Health News Source Type: news

Hundreds of 'natural' supplements contain active drugs and the FDA knows but doesn't tell the public
From 2007 to 2016, the US Food and Drug Administration found drugs in 776 supplements, but recalled less than half of them, a new California Department of Food and Agriculture study found. (Source: the Mail online | Health)
Source: the Mail online | Health - October 12, 2018 Category: Consumer Health News Source Type: news

FDA expands investigation of illegal e-cigarette marketing to kids
The US Food and Drug Administration pressed forward with its investigation of e-cigarette companies Friday, sending letters to 21 companies in an effort to uncover whether they are marketing products illegally and outside the agency's compliance policy. (Source: CNN.com - Health)
Source: CNN.com - Health - October 12, 2018 Category: Consumer Health News Source Type: news

FDA Approves New DNA-Based Test to Verify Blood Compatibility
FRIDAY, Oct. 12, 2018 -- The U.S. Food and Drug Administration has approved the ID CORE XT DNA-based test to help doctors verify blood compatibility before a transfusion. Patients who need repeated transfusions, such as those with sickle cell... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - October 12, 2018 Category: Pharmaceuticals Source Type: news

FDA warns e-cigarette makers against marketing to children
The Food and Drug Administration sent letters Friday to e-cigarette makers and importers, saying it will remove the products if they've been marketed illegally. (Source: Health News - UPI.com)
Source: Health News - UPI.com - October 12, 2018 Category: Consumer Health News Source Type: news

FDA lifts hold on first-ever CRISPR/Cas9 gene-editing trial
The U.S. Food and Drug Administration (FDA) lifted its hold on CRISPR Therapeutics and Vertex Pharmaceuticals' highly anticipated gene-editing trial Wednesday, allowing the first company-backed trial using the CRISPR/Cas9 technology to start in the U.S. CRISPR (Nasdaq: CRSP) and Vertex (Nasdaq: VRTX) were preparing to test the the ability of a new gene-editing technology, CRISPR/Cas9, in cutting out and replacing disease-causing snippets of DNA when the FDA placed the hold in May. The trial is… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - October 12, 2018 Category: Biotechnology Authors: Allison DeAngelis Source Type: news

Hundreds of health, weight loss products contain unapproved ingredients: Study
Researchers found 746 over-the-counter supplements contained potentially harmful and undeclared ingredients not approved by the Food and Drug Administration. (Source: Health News - UPI.com)
Source: Health News - UPI.com - October 12, 2018 Category: Consumer Health News Source Type: news

Nearly 800 dietary supplements contained unapproved drug ingredients, study finds
Nearly 800 dietary supplements sold over the counter from 2007 through 2016 contained unapproved drug ingredients, a new analysis of US Food and Drug Administration data found. More than one unapproved pharmaceutical ingredient was found in 20% of those supplements, the study published Friday in JAMA Network Open showed. (Source: CNN.com - Health)
Source: CNN.com - Health - October 12, 2018 Category: Consumer Health News Source Type: news

FDA advances investigation into whether more than 40 e-cigarette products are being illegally marketed and outside agency's compliance policy
(Source: Food and Drug Administration)
Source: Food and Drug Administration - October 12, 2018 Category: American Health Source Type: news

In crackdown, U.S. FDA seeks details on new electronic cigarettes
Faced with a proliferation of new electronic cigarettes and a sharp rise in teen vaping, the U.S. Food and Drug Administration on Friday sent letters to 21 electronic cigarette manufacturers seeking information to assess whether the products are being marketed illegally. (Source: Reuters: Health)
Source: Reuters: Health - October 12, 2018 Category: Consumer Health News Tags: healthNews Source Type: news