Safety reporting to FDA : Time lines

We have received lot of requests to write about Safety related reporting, coding and regulation. This blog will feature these aspects for the next 10 days, if you wish us to write on a specific topic please email us at contact@clinnovo.com. Thanks for your interest.

Pre-Approval - To IND

1. Unexpected fatal or life-threatening experience associated with the use of the drug
   
• 7 calendar day reports (telephone or fax)
2. From All Studies Worldwide (Serious, Drug-Related and Unexpected)
   
   • 15 calendar day reports (telephone or fax)
3. Findings from long term tox tests in laboratory animals suggesting a significant risk to humans (mutagenicity, teratogenicity, carcinogenicity) 
• 15 calendar day reports (telephone or fax)
4. Spontaneous Reports from Marketing Outside the U.S. (Serious and Unexpected)
• 15 calendar day reports (telephone or fax)
5. Reports in the scientific literature including unpublished manuscripts (Serious and Unexpected)
• 15 calendar day reports (telephone or fax)
6. Reports from foreign regulatory authorities (Serious and Unexpected)
• 15 calendar day reports (telephone or fax)
7. From Studies Worldwide (Serious)
• Annual IND reports

Post-Approval - To IND

1. From IND Studies (Serious, Drug-Related and Unexpected)
   
• 15 calendar day reports (telephone or fax)
2. From IND Studies (Serious)
   
   • 15 calendar day reports (telephone or fax)

Post-Approval - To NDA

1. From All Studies Worldwide (Serious, Drug-Related and Unexpected)
   
• 15 calendar day reports (telephone or fax)
2. Spontaneous Reports Worldwide (Serious and Unexpected)
   
   • Spontaneous and Periodic

Consequences of not following the schedule 

• Pre-Approval - Termination of IND
  
  • 21 CFR 312.44 in Phase 1, 2 or 3 : (b)(1)(vii) “The sponsor fails promptly to investigate and inform the Food and Drug Administration and all investigators of serious and unexpected adverse experiences in accordance with part 312 section 32 or fails to make any other report required under this part.
• Post-Approval- Withdrawal of NDA
• 21 CFR 314.80 (K) : "If an applicant fails to establish and maintain records and make reports required under this section FDA may withdraw approval of the application and, thus, prohibit continued marketing of the drug product that is the subject of the application.”