An Authorized U.S. Agent is required for non-U.S. applicants.
Application type: select one: New Drug Application (NDA), Abbreviated New Drug Application (ANDA) or Biologics License Application (BLA).
Samples: submit only upon FDA's request.
Signatures: the form has a signature line for the Applicant's Responsible Official or Other Authorized Official and a countersignature line for the Authorized U.S. Agent.
PRA Staff: do not send your completed form to the PRA Staff email address; it is for comments on the burden estimate.
| Question | Answer |
|---|---|
| Form Name | Form FDA 356h |
| Form Length | 4 pages |
| Fillable? | Yes |
| Fillable fields | 1624 |
| Avg. time to fill out | 60+ min |
| Edition | 05/26 |
| Issuing agency | Food and Drug Administration |
| Matches the agency's file | Yes, checked October 2, 2026 |
| Other names | FDA 356h, 356h, Form 356h, FDA Form 356h, 356 h form |
| Official source | Form FDA 356h (Rev 05/26), Food and Drug Administration |
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