Tag: Food and Drug Administration (FDA)

Epinephrine Auto-Injector

Sporadic Shortages of Epinephrine Devices Continue

Though epinephrine is currently readily available, emergency devices from specific manufacturers are experiencing sporadic shortages.
EpiPen Malfunctions

FDA Warns of Possible Malfunctions for EpiPen, EpiPen Jr, and Mylan’s...

Devices may potentially have delayed injection or be prevented from properly injecting.
Viaskin-Patch-Delay

FDA Has Questions About Viaskin Peanut Efficacy, Delays Meeting with DBV...

The company warned the FDA's target date for their decision on approval could be delayed.
Palforzia Capsules with Logo

Aimmune Provides FDA Mandated Program for Patients Considering Treatment of Peanut...

The FDA seeks to mitigate risks associated with treatment by mandating a program that must be followed by patients, prescribers, pharmacies, and healthcare settings.
Viaskin-Patch

FDA Advisory Committee Meeting to Review Viaskin Peanut for the Treatment...

Next step in the approval process for the therapy scheduled for May 15, 2020.
AAAAI Palforzia Release

What You Need to Know About the First Peanut Allergy Treatment...

Information for patients and their families about this new treatment option, what it means, and why it won’t be right for everyone.
Palforzia

FDA Approves Aimmune’s PALFORZIA as First Treatment for Peanut Allergy

Palforzia is an oral immunotherapy indicated for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut.
Thanksgiving Meal

Advisory to Those Preparing Holiday Meals for Guests with Food Allergies

Preparing meals for guests with food allergies is especially difficult due to lax US labeling requirements.
Fish in Popcorn

Undeclared Fish in Popcorn? Why Shared Line/Facility Info is So Important

It is of critical importance that you understand how a product is manufactured with respect to your allergens of concern.