Skip to main content

Tagged With "FDA"

Blog Post

DBV to Resubmit Viaskin Peanut Treatment for FDA Biologics License

KFA News Team ·
Kids With Food Allergies is sharing this press release from DBV Technologies to bring you the latest research news quickly. [PRESS RELEASE] DBV Technologies Provides Update on Regulatory Status of Viaskin Peanut for the Treatment of PeanutAllergic Children 4 to 11 Years of Age Progress made to date to enable BLA resubmission in Q3 2019 Company to hold conference call today, February 13th, at 4:30 ET / 22:30 CET DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market:...
Blog Post

Do the Food Allergen Labeling Laws Apply to Cosmetics?

Kids With Food Allergies ·
From lip balm and shampoo to moisturizers and eye shadow, cosmetics are overseen by the Food & Drug Administration (FDA). Even though these products go on our lips and skin, the FDA provides a lot less oversight than you might expect. In fact, most of the time the government does not get involved until there is a problem. Here’s what you need to know. What are “cosmetics”? The government defines “cosmetics” based on how the product is meant to be used. Cosmetics are meant to be rubbed,...
Blog Post

Epinephrine Nasal Spray Gets Fast Track Status From FDA as a Possible Treatment for Life-Threatening Food Allergy Reactions

KFA News Team ·
INSYS Therapeutics, Inc. (NASDAQ: INSY), a leader in the development, manufacture and commercialization of pharmaceutical cannabinoids and spray technology, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the company’s epinephrine nasal spray as an investigational treatment for anaphylaxis, an acute, life-threatening allergic reaction requiring urgent treatment.
Blog Post

FDA Accepts Application for Viaskin Peanut Patch for Review

KFA News Team ·
DBV Technologies, a clinical-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for its investigational Viaskin® Peanut immunotherapy for the treatment of peanut-allergic children ages 4 to 11 years. Viaskin Peanut is the Company’s lead product candidate designed to potentially reduce the risk of life-threatening allergic reactions due to accidental exposure to peanuts.
Blog Post

FDA Alerts Patients and Health Care Professionals of EpiPen Auto-Injector Errors Related to Device Malfunctions and User Administration

KFA News Team ·
FDA is alerting patients, caregivers and health care professionals that EpiPen 0.3mg and EpiPen Jr 0.15mg auto-injectors, and the authorized generic versions, may potentially have delayed injection or be prevented from properly injecting due to device failure and user error.
Blog Post

FDA Allows Peanut Immunotherapy Treatments to Advance

KFA News Team ·
  The Food and Drug Administration (FDA) agreed to expedite the review of a specially formulated peanut product. The peanut product, called AR101, is being studied as a potential allergy treatment. The status was granted after the company...
Blog Post

FDA Approves Eucrisa for Eczema

Kids With Food Allergies ·
The U.S. Food and Drug Administration today approved Eucrisa (crisaborole) ointment to treat mild to moderate eczema (atopic dermatitis) in patients two years of age and older.
Blog Post Featured

FDA Approves First Generic Competitor of EpiPen Epinephrine Auto-Injector

KFA News Team ·
The U.S. Food and Drug Administration today approved the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector for the emergency treatment of allergic reactions, including those that are life-threatening (anaphylaxis), in adults and pediatric patients who weigh more than 33 pounds. Teva Pharmaceuticals USA gained approval to market its generic epinephrine auto-injector in 0.3 mg and 0.15 mg strengths.
Blog Post

FDA Approves Lower Dose of Symjepi Epinephrine for Severe Allergic Reactions

KFA News Team ·
Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) (“Adamis”) today announced that the U.S. Food and Drug Administration (“FDA”) has approved Adamis’ lower dose version (0.15mg) of Symjepi ™ for the emergency treatment of allergic reactions (Type I) including anaphylaxis.
Blog Post

FDA Approves New Flu Treatment

KFA News Team ·
Today, the U.S. Food and Drug Administration approved Xofluza (baloxavir marboxil) for the treatment of acute uncomplicated influenza (flu) in patients 12 years of age and older who have been symptomatic for no more than 48 hours.
Blog Post

FDA Extends Expiration Dates of Certain Lots of EpiPens®

KFA News Team ·
The U.S. Food and Drug Administration today took additional action to mitigate shortages of EpiPen (epinephrine) auto-injector by extending the expiration date of specific lots of 0.3 milligram products marketed by Mylan by four months beyond the labeled expiration date.
Blog Post Featured

FDA Extends Expiration Dates of All Lots of EpiPens® and Authorized Generic

KFA News Team ·
As supply interruptions and shortages of epinephrine auto-injectors continue, the FDA has extended the expiration dates of all lots of EpiPen® (epinephrine injection, USP) 0.3 mg Auto-Injectors and its authorized generic version currently on the market in the U.S. after a review of stability data. Read more for the new expiration dates.
Blog Post

FDA: Foods Must Contain What Label States

Kids With Food Allergies ·
FDA: Foods Must Contain What Label SaysFebruary 4, 2013 As someone who cares about what your family eats, you make it a practice when shopping to read the labels on food packages.  And you have the right to expect that the information on the...
Blog Post

FDA Gives Experimental Peanut Allergy Patch Special Status Designed to Speed Review

Kids With Food Allergies ·
The Food and Drug Administration agreed to review a skin patch for peanut allergy on an expedited basis following positive results of recent clinical trials, the company said Thursday.   DBV Technologies said that the FDA granted its Viaskin...
Blog Post

FDA Modernizes Nutrition Facts Label for Packaged Foods

Kids With Food Allergies ·
Kids With Food Allergies is providing this information from the FDA so you can stay informed about changes in the Nutritional Facts label on packaged foods. Be aware this redesign does not change how allergens are labeled . Stay up-to-date on breaking news about food allergies, nutrition updates and allergy-friendly recipes and join or login to our community today! For Immediate Release May 20, 2016 Today, the U.S. Food and Drug Administration took a major step in making sure consumers have...
Blog Post

FDA Study Finds Milk in Most Dark Chocolate, No Matter What Label Says

Kids With Food Allergies ·
This FDA Consumer Update sheds further light on the results of an FDA study on milk in dark chocolate shared previously . For more detail,  read the study results .   In This Update: Read ‘May’ as ‘Likely’ Not Quite...
Blog Post

FDA Updates Instructions for EpiPens and Other Epinephrine Auto-Injectors

Kids With Food Allergies ·
The FDA announced changes to the labeling for epinephrine auto-injectors to help patients and caregivers use the medication appropriately in the event of anaphylaxis (anna-fih-LACK-sis). Anaphylaxis is a serious allergic reaction. Epinephrine is always the first treatment for serious allergic reactions . For all epinephrine auto-injectors: Hold the patient's leg and keep the leg steady while you inject the epinephrine This will help prevent the needles from cutting the thigh or becoming...
Blog Post

FDA Application for Peanut Patch for Children 4 to 11 Years of Age Is Withdrawn

KFA News Team ·
DBV Technologies today announced that after discussions with the U.S. Food and Drug Administration (FDA), its Biologics License Application (BLA) for Viaskin Peanut in children four to 11 years of age has been voluntarily withdrawn. DBV is currently working closely with the agency to resubmit the application for Viaskin Peanut as quickly as possible.
Blog Post Featured

Breaking News: FDA Approves Palforzia, a Ground-Breaking Peanut Allergy Oral Immunotherapy Treatment

KFA News Team ·
On Jan. 31, 2020, the U.S. Food and Drug Administration (FDA) announced its approval of Aimmune Therapeutics’ peanut treatment, Palforzia, for children ages 4 to 17. This is big news for the food allergy community. Food allergies put a significant mental, social and financial burden on families. Until now, strict avoidance has been the only way to avoid allergic reactions. Palforzia may give many families managing peanut allergies more freedom and greater quality of life.
Blog Post

DBV Resubmits Viaskin Peanut Allergy Treatment to FDA

KFA News Team ·
DBV Technologies, a clinical-stage biopharmaceutical company, today announced the submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for Viaskin® Peanut for the treatment of peanut-allergic children ages 4 to 11 years.
Blog Post

How to Report Foods After an Allergic Reaction

Kids With Food Allergies ·
If you suspect your child had an allergic reaction to a mislabeled food, you can report it. By doing so, you can help play an important role in public health.
Blog Post

17% of Children With Food Allergies May Have a Sesame Allergy

KFA News Team ·
Investigators at the National Institutes of Health have found that sesame allergy is common among children with other food allergies, occurring in an estimated 17% of this population. In addition, the scientists have found that sesame antibody testing—whose utility has been controversial—accurately predicts whether a child with food allergy is allergic to sesame. The research was published on Oct. 28 in the journal Pediatric Allergy and Immunology.
Blog Post

AAFA Applauds FDA First Steps Toward Declaring Sesame as Major Allergen

KFA News Team ·
The Asthma and Allergy Foundation of America (AAFA), the premiere nonprofit representing patients with asthma and allergies, applauds the recent request for information and statement from the Food and Drug Administration (FDA) demonstrating its commitment to explore the classification of sesame as a major allergen. Kids With Food Allergies is a division of AAFA.
Blog Post Featured

AAFA Brings Patient Voice to FDA Committee Review on Palforzia, Oral Immunotherapy Treatment for Peanut Allergy

Kids With Food Allergies ·
On Sept. 13, 2019, the U.S. Food and Drug Administration’s (FDA) Allergenic Products Advisory Committee recommended the approval of Aimmune Therapeutics’ peanut treatment, Palforzia. If approved, Palforzia would be ground-breaking for the future of food allergy treatments. What Is Palforzia? Palforzia, also known as AR101, is a type of oral immunotherapy (OIT) for peanut allergy. If approved, it would be the first FDA-approved treatment for peanut allergy. Currently, some allergists already...
Blog Post

AAFA Joins Other Groups to Release Statement on Impact of Government Shutdown on FDA's Review of Food Allergy Treatments

Kids With Food Allergies ·
The Asthma and Allergy Foundation of America (AAFA) has joined with the Allergy & Asthma Network, the Center for Science in the Public Interest and Food Allergy Research & Education to issue a statement about the current government shut down and its impact on the Food and Drug Administration's (FDA) review of food allergy therapies.
Blog Post

AAFA Responds to FDA Cumin Warning

Kids With Food Allergies ·
This week, the Food and Drug Administration issued a warning to people with peanut allergies, advising them to consider staying away from all food products containing ground cumin or cumin powder after a wave of recalls. Ground cumin, apparently...
Blog Post

U.S. Updating Rules for Food Manufacturers With Food Allergies in Mind

Kids With Food Allergies ·
Have you read about changes to U.S. food manufacturing practices? Are you confused? In this post, we explain some of the changes and what it means if you have food allergies. What Are Good Manufacturing Practices? The U.S. has rules that establish “Good Manufacturing Practices” (GMP) for food manufacturers to follow. These practices help to lessen the risk of danger to the public. They require manufacturers to follow good food hygiene and handling methods. Most facilities that manufacture...
Blog Post

What Progress Is Being Made to Improve Sesame Labeling?

Kids With Food Allergies ·
Sesame labeling has been a common topic in the news and our community recently. We wanted to give you an update on progress we’ve made advocating for better sesame labeling.
Blog Post

Proposed Federal Bill Adds Sesame to List of Major Allergens

Kids With Food Allergies ·
An important bill in Congress adds sesame to the list of major allergens that must be declared on a food label. Currently, only eight allergens - milk, eggs, fish, shellfish, tree nuts, peanuts, wheat and soy - are listed on food labels . Allergens not on that list - such as sesame – are sometimes called non top-8 allergens. The Food Labeling Modernization Act of 2015 (HR 4061) would make sesame the ninth allergen regulated by the Food and Drug Administration (FDA). In addition, the...
Blog Post

It’s Time to Label Sesame a Major Allergen

Kids With Food Allergies ·
For people with food allergies, accurate food labels are important. Ingredient labels became clearer when the Food Allergen Labeling and Consumer Protection Act went into effect in 2006 – at least for those allergic to one of the top eight major food allergens. The Food and Drug Administration (FDA) considers milk, eggs, fish, crustacean shellfish, tree nuts, wheat, peanuts and soybeans as major food allergens.
Blog Post

Label Reading Reminder: Look Out for Similar Packaging or Separate Items Within a Package

KFA Food Bloggers ·
Label reading is a critical part of managing your child's food allergies. But it can often be confusing. For example, it's not uncommon for companies to sell food in similar packaging even though they have similar ingredients.
Blog Post Featured

Share Your Allergy Reactions to Sesame With the FDA

Kids With Food Allergies ·
Sesame allergy ranks ninth in prevalence behind the top 8 allergens. But manufacturers are not required to clearly label sesame on their products. It can even go unlabeled under terms like “spices” and “natural flavoring.” This is very distressing as reactions to sesame can be among the most severe for adults and children. We are asking community members who have had an adverse reaction to sesame, or care for someone who has, to share their story with the FDA.
Blog Post

Generic Montelukast and Singulair Will Now Carry Stronger Warning Label About Possible Side Effects

KFA News Team ·
The U.S. Food and Drug Administration today announced that it is requiring a boxed warning – the agency’s most prominent warning – for montelukast (sold under the brand name Singulair and in generic form) to strengthen an existing warning about the risk of neuropsychiatric events associated with the drug, which is used to treat asthma and allergic rhinitis (hay fever).
Blog Post

Think Your Dark Chocolate is Dairy Free? Better Call the Company

Kids With Food Allergies ·
The Food and Drug Administration is warning consumers that the dark chocolate you purchased may likely have milk in it – even, in two cases, products labeled “dairy free.”   The FDA study tested 100 dark chocolate products and...
Blog Post

New Study Shows Sesame Allergy May Be More Common Than Some Top 8 Food Allergies

KFA News Team ·
Recently, the FDA has been asking for more data to support adding sesame to the list of top food allergens. A new study titled “Prevalence and Severity of Sesame Allergy in the United States” has been released by the JAMA Network today in response to the FDA’s request.
Comment

Re: U.S. Updating Rules for Food Manufacturers With Food Allergies in Mind

Katie D ·
It is encouraging to see these changes being made, and I hope we start to see a decline in the number of recalls we see along with better management and education of allergens within manufacturing facilities. I did not know that the FDA didn't have the ability to force a recall for mislabeled products and that it was up to the manufacturer, this is a move in the right direction for sure. To the facilities have to have procedures in place to ensure that their products are not cross...
Comment

Re: Do the Food Allergen Labeling Laws Apply to Cosmetics?

texasgirl ·
I have learned of a company that uses non toxic chemicals and is transparent with the ingredients. They actually support labeling for the cosmetic industry.
Comment

Re: Do the Food Allergen Labeling Laws Apply to Cosmetics?

Jen ·
What company?
Comment

Re: Do the Food Allergen Labeling Laws Apply to Cosmetics?

StephC ·
There's also www.KissFreely.com, free from top 8.
Comment

Re: Do the Food Allergen Labeling Laws Apply to Cosmetics?

K8sMom2002 ·
@texasgirl Just wondering what the company name was you had found ... DD has to avoid corn, and that can be hard for a girl who likes makeup as much as she does!
Comment

Re: Do the Food Allergen Labeling Laws Apply to Cosmetics?

texasgirl ·
www.beautycounter.com/kristieserio The company is Beautycounter.
Comment

Re: Epinephrine Nasal Spray Gets Fast Track Status From FDA as a Possible Treatment for Life-Threatening Food Allergy Reactions

Momofthree ·
This would be amazing! Will be interesting to see the cost comparison to the auto injector.
Comment

Re: Epinephrine Nasal Spray Gets Fast Track Status From FDA as a Possible Treatment for Life-Threatening Food Allergy Reactions

goodsammy ·
This will eliminate the necessity of training to administer epinephrene. Even after getting trained, a lot of people are hesitant to give the injection and things get delayed. If this spray gets approved, it has the potential to save a lot of lives.
Comment

Re: Breaking News: FDA Approves Palforzia, a Ground-Breaking Peanut Allergy Oral Immunotherapy Treatment

A-Ma ·
Curious what folks are finding (beyond clinical trials) in side effects, symptoms, success and failures with kids with multiple food allergies
Comment

Re: AAFA Joins Other Groups to Release Statement on Impact of Government Shutdown on FDA's Review of Food Allergy Treatments

Fredric ·
“Delays of any kind prolong the long wait for a potentially life-saving therapy for peanut allergy.” Should read for food allergies. Not just specifically for peanut allergy. Respectfully, Fred Adler > On Jan 22, 2019, at 2:28 PM, Kids With Food Allergies < support@aafa.org > wrote: > > Delays of any kind prolong the long wait for a potentially life-saving therapy for peanut allergy.
Comment

Re: Label Reading Reminder: Look Out for Similar Packaging or Separate Items Within a Package

Sunny5 ·
Thank you for reminder to Read labels and not get relaxed on reading common products as safe. I am very worried about cupcakes label said PEANUT FREE Facility BUT...i never seen strawberry cupcakes so decided to read label it said nuts n pecans in ingredients...i s so glad i read ..my daughter is allergic to nuts ALL nut and i was taking them to school for LAST DAY OF SCHOOL SNACK TO CHANGE OUT THE TEACHERS SNACKS FOR SAFE TREATS ..SCARY!! AND im discusted the label said peanut free sticker...
Comment

Re: Label Reading Reminder: Look Out for Similar Packaging or Separate Items Within a Package

Kathy P ·
Hi Sunny - that sounds really scary and I'm so glad you checked the label so thoroughly. Peanut and tree nuts are different allergens, so something can be peanut free but not tree nut free...and vice versa. Thank you for the reminder to not make assumptions about labeling "claims" and always read the full ingredients label.
Comment

Re: Label Reading Reminder: Look Out for Similar Packaging or Separate Items Within a Package

K8sMom2002 ·
Wow, that was a great catch, Sunny! Does your daughter avoid both peanuts and tree nuts? Here's a great resource that's helped me understand labeling ... FAQ About the Food Allergen Labeling Consumer Protection Act . It was eye-opening how many exceptions there were!
 
Kids With Food Allergies
A Division of the Asthma and Allergy Foundation of America
1235 South Clark Street Suite 305, Arlington, VA 22202
Phone: 1-800-7-ASTHMA (1.800.727.8462)
-->
×
×
×
×