| Title: | FDA Programming Reminder for PG24 |
|---|---|
| Date: | 2017-12-15 |
| To: | abi,newace,partner |
| Links: | previous, original, next |
As per FDA's Supplemental Guide, https://www.cbp.gov/document/guidance/fda-supplemental-guide-release-16, only one PG24 Remarks record is allowed per PG02; IE only one PG24 is allowed per FDA line and remarks type must be “GEN”. FDA has received many entries with multiple PG24 records. When multiple PG24 Remarks records are received, FDA is only able to process one record. Failure to follow Supplemental Guide instructions will prevent FDA field staff from receiving remarks entered by the filer and could cause delays in review or prevent processing.
For ACE inquiries, contact FDA ACE Support at ACE_Support@fda.hhs.gov or 877-345-1101, from 6:00 AM -10:00 PM Eastern, 7 days a week.
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