Complete Response Letter NDA 505b1 218762 (Apr 17, 2024)

Summary

This section serves as an attestation for an electronic record, confirming it was signed electronically and providing details of the electronic signature, including the date, time, and a reference ID.

Key points

• The document must be identified as an electronic record.
• The document must have been signed electronically.
• Manifestations of all electronic signatures for the record must be included.
• The date and time of the electronic signature must be recorded.
• A unique reference ID for the record should be provided.
• Respond to agency requests within the prescribed timeline.

Cited reasons

• Agency deficiencies
• No specific deficiencies could be extracted from the provided truncated letter.

Recommended actions

• The document must be identified as an electronic record.
• The document must have been signed electronically.
• Manifestations of all electronic signatures for the record must be included.
• The date and time of the electronic signature must be recorded.
• A unique reference ID for the record should be provided.

Deficiency summary

No specific deficiencies could be extracted from the provided truncated letter.

Findings

Regulatory context

Submission stage

final decision

Regulatory pathway

NDA

Impact

Impact score

0.75

Estimated delay

180 days

Estimated rework cost

$0

Subsequent action

resubmission

Strategic insights

No specific themes could be extracted from the provided truncated letter.

Regulatory change impact: Pending sponsor mitigation plan

Approval likelihood after response: 25%