DesBio/Deseret Biologicals, Inc.
1 extracted findings
FDA source excerpt, selected passage
No approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for this product.***1*** Accordingly, this product is an unapproved new drug.
Findings and supporting evidence
Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.
Findings extracted from the letter
Selected FDA passages, not the complete letter.
01
No approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for this product.***1*** Accordingly, this product is an unapproved new drug.
Source passage selected by the model
Sections and clauses cited
As cited in this historical letter, not a statement of current regulatory requirements.