UCLA: Ga68-PSMA
FDA untitled letter, 28 December 2017. A UCLA webpage and brochure presented the investigational PET imaging agent Ga68-PSMA as safe and effective for detecting prostate cancer cells. FDA objected that this was promotion of an investigational drug that FDA has not approved for any use.
The letter
- Date
- 28 December 2017
- Type
- Untitled letter (OPDP)
- Product
- Gallium 68 (68GA-PSMA) (Prostate Cancer Imaging webpage and brochure)
- FDA matter number
- MA 1
- Promoted piece
- UCLA webpage and brochure on PSMA-PET imaging
- Aimed at
- Consumers (DTC)
- Format
- Website, Brochure or leave-behind
- Came in under Form FDA 2253
- The letter does not say
- Close-out
- FDA's source does not say whether this letter was closed out.
What FDA cited
The categories below are this tool's labels, read from the letter. Each quote is FDA's own wording, copied from the letter.
- Broader use than approved
“these claims and presentations suggest in a promotional context that Ga68-PSMA , an investigational new drug, is safe or effective for”
Check your claims before FDA does
Arca reads a promotional piece against the approved labeling and the references it cites, and flags each claim the label does not support. See how Arca supports MLR review. Back to the OPDP letter search.