Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

We arecurrently running an oncology clinical trial of marketed drugs in combination with an investigational drug.  What is our safety reporting obligations on the marketed drugs (brand names and generics).  There is no safety data exchange agreement (SDEA) between the sponsor of the investigatoinal drugs and the marketing authorizatoin holder. 

In this case is the following accurate?
- Nofity the marketing authorization holder of any SUSARs attributed to their drug within 5 days (per CFR 314.80)?
- Nofity within an appropriate time period of the AEs for their PSUR? 
- what about Generics drug used in the study? Same rules? 

We have an SDEA for one of the marketed product with the MAH - so there is clear expectations.

This message was posted by a user wishing to remain anonymous

Most importantly notify your IND followed by, as you said, original NDA holder of the marketed products!
PSUR is original NDA holders responsibility and in fact they would approach you for any further information to support their PSUR.

Only the manufacturer of that specific ANDA drug holder which is being used in your IND, not all other ANDA drug holders!

Hope this helps!
Original Message:
Sent: 13-Feb-2022 00:24
From: Anonymous Member
Subject: Safety reporting of approved drugs in combination with investigational drugs in clincial trials

This message was posted by a user wishing to remain anonymous

We arecurrently running an oncology clinical trial of marketed drugs in combination with an investigational drug.  What is our safety reporting obligations on the marketed drugs (brand names and generics).  There is no safety data exchange agreement (SDEA) between the sponsor of the investigatoinal drugs and the marketing authorizatoin holder.

In this case is the following accurate?
- Nofity the marketing authorization holder of any SUSARs attributed to their drug within 5 days (per CFR 314.80)?
- Nofity within an appropriate time period of the AEs for their PSUR?
- what about Generics drug used in the study? Same rules?

We have an SDEA for one of the marketed product with the MAH - so there is clear expectations.