Signs Point to Stricter Enforcement of FDA Fillable Forms
May31

Signs Point to Stricter Enforcement of FDA Fillable Forms

In recent weeks, sponsors filing eCTD submissions to FDA have reported instances of Refuse to Receive (RTR) notifications for failure to provide a fillable Form 3674. These actions indicate that the Agency is stepping up enforcement in this area as it aims to process even more submissions automatically. Using industry presentations and guidance documents, FDA has previously stated that sponsors “must” include fillable forms. The Agency has also made it clear that scanned images of FDA forms “will not be accepted.” Based on the information made public by FDA to date and the experience of sponsors in recent months, the most logical strategy moving forward is to provide a fillable form where one is available.

Read More