Tag: FDA Complete Response Letter (CRL)
ARS Responds to FDA’s Request for Additional Study Before Approving neffy...
FDA Issues Complete Response Letter for neffy® New Drug Application with Request for Additional Study.
FDA Denies Approval of Viaskin Peanut “Patch” Therapy
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?
An alternative to the epinephrine auto-injector has been accepted by the FDA for consideration.
Epinephrine Auto-injectors: Where is the Long Promised Generic?
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
More study required as result of changes made to product in response to prior rejection.
