Tag: FDA Complete Response Letter (CRL)

Viaskin Peanut

FDA Denies Approval of Viaskin Peanut “Patch” Therapy

Dave Bloom -
The FDA raised concerns that adhesion of the patch would affect the efficacy of the therapy.

Adamis Pre-Filled Syringe: Is Third Time a Charm?

Dave Bloom -
An alternative to the epinephrine auto-injector has been accepted by the FDA for consideration.
Teva Generic

Epinephrine Auto-injectors: Where is the Long Promised Generic?

Dave Bloom -
We were supposed to have a generic alternative last year. What's holding it up and when can we expect it?

Adamis Auto-Injector Rejected by FDA

Dave Bloom -
More study required as result of changes made to product in response to prior rejection.
SnackSafely.com

Established in 2011, SnackSafely.com provides straightforward, actionable information to help improve the lives of the estimated 32 million people in the US suffering with food allergies.

We strive to eliminate anaphylaxis by leveraging our on-line properties to educate, advocate, and connect the allergic community with products and services that help toward achieving this goal.

Our blog covers topics of interest to the food allergy community including news reports; ongoing research, clinical studies, trials and progress toward treatment and cure; general advocacy; and advice regarding food safety and school policies.

Please see our Terms of service and Privacy Policy.

SnackSafely.com, PO Box 141, Hillsdale, NJ 07642

©2020 SnackSafely.com Inc. All rights reserved.