Allovate Therapeutics, LLC
4 extracted findings · 2 model-assigned issue types
FDA source excerpt, selected passage
your product is an unapproved new drug in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a).
Findings and supporting evidence
Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.
The product is an unapproved new drug under FD&C Act section 505(a) because it lacks an approved application.
Supporting FDA text
Source excerpt · automated text-match checkyour product is an unapproved new drug in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a).
The product is an unlicensed biological product under PHS Act section 351(a)(1) because no BLA is in effect.
Supporting FDA text
Source excerpt · automated text-match checkYour product is also an unlicensed biological product in violation of section 351(a)(1) of the Public Health Service Act (PHS Act), 42 U.S.C. § 262(a)(1).
The product is intended for disease treatment or prevention and to affect body function, making it a drug and biological product.
Supporting FDA text
Source excerpt · automated text-match checkyour product is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or conditions in humans and/or is intended to affect the structure or function of the body. For example, your brochure states, “With Allerdent you can experience allergy immunotherapy while simply brushing your teeth every day. This is known as oral mucosal immunotherapy, or OMIT”.
The product is a biological product as defined by the PHS Act and lacks an approved BLA.
Supporting FDA text
Source excerpt · automated text-match checka biological product as defined in section 351(i) of the PHS Act, 42 U.S.C. § 262(i).
Findings extracted from the letter
Selected FDA passages, not the complete letter.
Source passage selected by the model
Source passage selected by the model
Source passage selected by the model
Source passage selected by the model
What FDA requested
Model-assisted summary. Consult the letter for complete requests and conditions.
- Submit a written response outlining specific steps taken or planned to address the violations and prevent recurrence.
- Include documentation necessary to show the matters have been addressed.
- If the matters cannot be addressed within 15 working days, explain the reason for delay and the timeframe for completion.
- If you believe the product is not in violation, include reasoning and supporting information.