On August 9, 2011, UNIVEC issued an official press release titled "UNIVEC Announces FDA Labeler Code Approval" After 24==months under FDA guidelines, an assigned labeler code that does not have any active, commercialized drug products listed under it will eventually be marked inactive by the agency....getting an FDA Labeler Code is the mandatory first step to creating a National Drug Code (NDC).
Why hasn't Dalton.....Secured a new FDA Labeler Code as its an inexpensive administrative step???
If the Reliefta Patch is marketed or framed as a prescription neuro-anesthetic patch, it legally crosses into prescription drug territory. In that scenario, it cannot be legally sold, distributed, or e-prescribed without:
1. An approved FDA NDA or ANDA.
2. Processing through a state-licensed pharmacy with a licensed pharmacist.
The FDA requires human clinical trial data before granting full approval. Bypassing human trials only happens under strict emergency provisions or special regulatory pathways like the Animal Rule.
Researched every major trial databases—including the National Institutes of Health (NIH) ClinicalTrials.gov registry, the FDA database, PubMed, and medical literature—yields zero clinical trials conducted on or registered for a product named "RELIEFTA" by Haygood Farms, UNIVEC, or 11 Three LLC, CentennialRx.
If anyone knows where else to research to find the trials, please post the links....
PL
Why hasn't Dalton.....Secured a new FDA Labeler Code as its an inexpensive administrative step???
If the Reliefta Patch is marketed or framed as a prescription neuro-anesthetic patch, it legally crosses into prescription drug territory. In that scenario, it cannot be legally sold, distributed, or e-prescribed without:
1. An approved FDA NDA or ANDA.
2. Processing through a state-licensed pharmacy with a licensed pharmacist.
The FDA requires human clinical trial data before granting full approval. Bypassing human trials only happens under strict emergency provisions or special regulatory pathways like the Animal Rule.
Researched every major trial databases—including the National Institutes of Health (NIH) ClinicalTrials.gov registry, the FDA database, PubMed, and medical literature—yields zero clinical trials conducted on or registered for a product named "RELIEFTA" by Haygood Farms, UNIVEC, or 11 Three LLC, CentennialRx.
If anyone knows where else to research to find the trials, please post the links....
PL
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