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Home
Safe Snack Guide
Peanut and Tree Nut Free Edition
Milk Free Edition
Sesame Free Edition
Gluten Free Edition
Custom Edition
Allergence
Coupons
About Us
Media Kit
Advertising Guide
Manufacturer Partnership
Subscribe to our newsletter
Contact Us
Resources
FAQ
Tools for Schools
Coupons
Search
Tag: FDA Complete Response Letter (CRL)
ARS Responds to FDA’s Request for Additional Study Before Approving neffy...
Dave Bloom
-
2023/09/20
FDA Issues Complete Response Letter for neffy® New Drug Application with Request for Additional Study.
FDA Denies Approval of Viaskin Peanut “Patch” Therapy
Dave Bloom
-
2020/08/04
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
-
2017/01/20
An alternative to the epinephrine auto-injector has been accepted by the FDA for consideration.
Epinephrine Auto-injectors: Where is the Long Promised Generic?
Dave Bloom
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2016/07/12
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
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2016/07/06
More study required as result of changes made to product in response to prior rejection.