IND Reporting Timelines

Question 1

When should you notify the FDA of a new Sub-I/PI?

Answer 1

Within 30 days of investigators start date

Question 2

When should you notify the FDA about amendments?

Answer 2

No more than 30 days

Question 3

When should you notify the FDA of a safety report?

Answer 3

Max 15 days after determining report is required

Question 3

When should you notify the FDA of safety reports- life threatening/fatal AEs?

Answer 3

Within 7 days of learning about the event

Question 4

When should you notify the FDA of safety reports- additional information?

Answer 4

Within 15 days of receiving FDA request

Question 5

When should you notify the FDA of safety reports- endpoint related AEs?

Answer 5

Within 15 days of determining it’s an AE

Question 6

When should you notify the FDA of annual reports?

Answer 6

Within 60 days of initial IND effective date

Question 7

When should you notify the FDA of termination response?

Answer 7

Within 30 days

Question 8

When should you notify the FDA of termination response- regulatory meeting request?

Answer 8

Within 10 days of receipt of FDA’s non-acceptance response

Question 9

How long should you retain documents post-market approval?

Answer 9

2 years

Question 10

How long should you retain documents post- market rejection?

Answer 10

2 years post-study closure + FDA notification

Question 11

How long should you retain PI record post-market approval?

Answer 11

2 years

Question 12

How long should you retain PI record no market approval (filed or not)

Answer 12

2 years post-study discontinuation

Question 13

When should you report SAEs to PI or sponsor?

Answer 13

Immediately upon learning about SAE but no more than 24 hours

Question 14

When should you report AEs to PI or sponsor?

Answer 14

Per protocol timeline

Question 15

How long should you retain records pertaining to international-initiated studies done in the US without an IND

Answer 15

*market application-2 years post-decision
*no market app-2 years post-IND submission

Question 16

How long should you retain records regarding Rx shipment for animal/in vitro studies?

Answer 16

2 years post shipment

Question 17

How long should you retain records of IND effective date?

Answer 17

30 days unless otherwise noted

Question 18

If a study is “in-active status” for an IND….

Answer 18

“*halt enrollment for 2 years
*clinical hold for 1 year
*sponsor has 30 days from receipt of status change to respond to the FDA”

Question 19

When should the end of phase 2 meeting take place?

Answer 19

before commitment/effort/resources have been devoted to transition from phase 2 to 3

Question 20

When should the submission of progression of a Phase 2 to Phase 3 trial take place?

Answer 20

At least 1 month before End of Phase 2 meeting

Question 21

Info needed for Pre-NDA, Pre-BLA meetings

Answer 21

Submit to FDA at least 1 month pre-meeting

Question 22

Procedure stop time post-study discontinuation determination

Answer 22

ASAP, but no later than 5 days

Question 23

IND Activation

Answer 23

30 days post-FDA receipt, or sooner if notified

Question 24

Protocol- emergency use

Answer 24

When authorized by the FDA reviewer over the phone

Question 25

Protocol- other use

Answer 25

30 days post-FDA receipt, or earlier upon notification

Question 26

Expanded access submission

Answer 26

Within 15 working days of FDA's authorization of Rx use