Regulatory Open Forum

Dear Industry experts,

Hope you are having good time.

You all may have already seen the updated MAPP 5200.14 Rev. 1 "Filing Review of Abbreviated New Drug Applications". I am wondering why this MAPP does not talk about Module 2.3: Quality Overall Summary (QOS), which we are submitting for ANDA following QbR format for drug substance (2.3.S) and drug product (2.3.P).

There are some other noticeable changes made in this MAPP. 

Your valuable thoughts regarding this will be highly appreciated. 

Dan,

Something like this?

The information herein is considered CONFIDENTIAL to [Company Name] per the provisions and exceptions of
21 CFR §20.61, 21 CFR §812.38, and 21 CFR §814.9.

Cheers,

Melissa

Dear Industry experts,

Hope you are having good time.

You all may have already seen the updated MAPP 5200.14 Rev. 1 "Filing Review of Abbreviated New Drug Applications". I am wondering why this MAPP does not talk about Module 2.3: Quality Overall Summary (QOS), which we are submitting for ANDA following QbR format for drug substance (2.3.S) and drug product (2.3.P).

There are some other noticeable changes made in this MAPP. 

Your valuable thoughts regarding this will be highly appreciated. 

Thanks you Madam for your valuable insights. 

Could you please suggest, if anyone intends to submit a new ANDA, should they follow the new MAPP and will not submit QOS to FDA?

Dan,

Something like this?

The information herein is considered CONFIDENTIAL to [Company Name] per the provisions and exceptions of
21 CFR §20.61, 21 CFR §812.38, and 21 CFR §814.9.

Cheers,

Melissa

Dear Industry experts,

Hope you are having good time.

You all may have already seen the updated MAPP 5200.14 Rev. 1 "Filing Review of Abbreviated New Drug Applications". I am wondering why this MAPP does not talk about Module 2.3: Quality Overall Summary (QOS), which we are submitting for ANDA following QbR format for drug substance (2.3.S) and drug product (2.3.P).

There are some other noticeable changes made in this MAPP. 

Your valuable thoughts regarding this will be highly appreciated. 

Dear Industry experts,

Hope you are having good time.

You all may have already seen the updated MAPP 5200.14 Rev. 1 "Filing Review of Abbreviated New Drug Applications". I am wondering why this MAPP does not talk about Module 2.3: Quality Overall Summary (QOS), which we are submitting for ANDA following QbR format for drug substance (2.3.S) and drug product (2.3.P).

There are some other noticeable changes made in this MAPP. 

Your valuable thoughts regarding this will be highly appreciated. 

Good observation Sujan. I think there was another MAPP 5241.3 Good Abbreviated New Drug Application Assessment Practices that was released on October 6, 2023 which aimed at making OGD reviews more efficient by focusing on critical areas. I think this MAPP 5200.14 was updated as a result of that. In my opinion you should be okay following the new MAPP. 

Dear Industry experts,

Hope you are having good time.

You all may have already seen the updated MAPP 5200.14 Rev. 1 "Filing Review of Abbreviated New Drug Applications". I am wondering why this MAPP does not talk about Module 2.3: Quality Overall Summary (QOS), which we are submitting for ANDA following QbR format for drug substance (2.3.S) and drug product (2.3.P).

There are some other noticeable changes made in this MAPP. 

Your valuable thoughts regarding this will be highly appreciated. 

Dear Sir,

Thank you for your valuable comments.

I am really concerned about QOS part of original ANDA submission. 

As I have cited earlier, QOS not available in the updated MAPP 5200.14 Rev. 1, however in the ANDA content and format guidance and 21 CFR Section 314.50(c)(2)(iv) it is available. In views of that, can a FDA reviewer RTR an ANDA for not submitting QOS with the original application? What would be best practice, with application with QOS or without QOS?

Looking forward to hear more from experts.

Good observation Sujan. I think there was another MAPP 5241.3 Good Abbreviated New Drug Application Assessment Practices that was released on October 6, 2023 which aimed at making OGD reviews more efficient by focusing on critical areas. I think this MAPP 5200.14 was updated as a result of that. In my opinion you should be okay following the new MAPP. 

Dear Industry experts,

Hope you are having good time.

You all may have already seen the updated MAPP 5200.14 Rev. 1 "Filing Review of Abbreviated New Drug Applications". I am wondering why this MAPP does not talk about Module 2.3: Quality Overall Summary (QOS), which we are submitting for ANDA following QbR format for drug substance (2.3.S) and drug product (2.3.P).

There are some other noticeable changes made in this MAPP. 

Your valuable thoughts regarding this will be highly appreciated. 

Dear Sir,

Thank you for your valuable comments.

I am really concerned about QOS part of original ANDA submission. 

As I have cited earlier, QOS not available in the updated MAPP 5200.14 Rev. 1, however in the ANDA content and format guidance and 21 CFR Section 314.50(c)(2)(iv) it is available. In views of that, can a FDA reviewer RTR an ANDA for not submitting QOS with the original application? What would be best practice, with application with QOS or without QOS?

Looking forward to hear more from experts.

Good observation Sujan. I think there was another MAPP 5241.3 Good Abbreviated New Drug Application Assessment Practices that was released on October 6, 2023 which aimed at making OGD reviews more efficient by focusing on critical areas. I think this MAPP 5200.14 was updated as a result of that. In my opinion you should be okay following the new MAPP. 

Dear Industry experts,

Hope you are having good time.

You all may have already seen the updated MAPP 5200.14 Rev. 1 "Filing Review of Abbreviated New Drug Applications". I am wondering why this MAPP does not talk about Module 2.3: Quality Overall Summary (QOS), which we are submitting for ANDA following QbR format for drug substance (2.3.S) and drug product (2.3.P).

There are some other noticeable changes made in this MAPP. 

Your valuable thoughts regarding this will be highly appreciated.