Regulatory Open Forum

Hello everyone,
I have seen that the MoCRA portal has finally opened in CDeR direct.
However, you have to change your account settings to CDeR and FDA Direct. In this way you can send drug as well as Cosmetic application request.
I just have a question, has anyone faced an issue that you are not able to submit as the save and validate and submit button seem to be missing.

Winston Costa Pereira
Sent from my iPhone

This message was posted by a user wishing to remain anonymous

Is that https://direct.fda.gov/ ?

Original Message:
Sent: 18-Dec-2023 07:48
From: Winston Costa Pereira
Subject: Regarding the MoCRA portal.

Hello everyone,
I have seen that the MoCRA portal has finally opened in CDeR direct.
However, you have to change your account settings to CDeR and FDA Direct. In this way you can send drug as well as Cosmetic application request.
I just have a question, has anyone faced an issue that you are not able to submit as the save and validate and submit button seem to be missing.

Winston Costa Pereira
Sent from my iPhone

Original Message:
Sent: 12/18/2023 9:18:00 AM
From: Anonymous Member
Subject: RE: Regarding the MoCRA portal.

This message was posted by a user wishing to remain anonymous

Is that https://direct.fda.gov/ ?

Original Message:
Sent: 18-Dec-2023 07:48
From: Winston Costa Pereira
Subject: Regarding the MoCRA portal.

Hello everyone,
I have seen that the MoCRA portal has finally opened in CDeR direct.
However, you have to change your account settings to CDeR and FDA Direct. In this way you can send drug as well as Cosmetic application request.
I just have a question, has anyone faced an issue that you are not able to submit as the save and validate and submit button seem to be missing.

Winston Costa Pereira
Sent from my iPhone