Regulatory Open Forum

Hello,

So, I've read a topic about "Hare or Tortoise" filing and was wondering if, as part of a "lean" submission, we can omit the Proprietary Name aspect of the submission package.
We are a small business that progress through partnerships. We haven't found a commercial partner for this product yet (that we intend to file a 505(b)(2) in Q2 2013), so performing a study on the appropriateness of a Proprietary Name is the big question since the potential might prefer another name (even this can be done as post-approval change).

Question: Is proprietary name approval required at the time of submission or can this be done post-approval but before commercialization?

Thank you.

Regards,

-------------------------------------------
Tom Namsavanh RAC
Manager, Regulatory Affairs and Compliance
Intelgenx Corp.
Saint-Laurent QC
Canada
-------------------------------------------

Tom,

You always ask such interesting questions. I would hope that your company is planning or has already requested your pre-NDA or BLA meeting or scientific advise meeting with RA authorities as this is the appropriate place to have this strategic discussion. Since you mention a 505(b)(2) type submission, I am assuming a submission to FDA.

Submission of a "trade" name is typically included in your filing and could result in a refusal to file your application as part of the check list prior to review; that is, is the application complete such that FDA would accept it for review.  A proprietary name is important such that FDA can evaluate any conflicts with similar therapies and their trade names with a focus to avoid prescription errors. 

Most companies, typically have their name vetted by an organization that evaluates the name for potential conflicts with other products such that the name at the time of submission has a high probability of being accepted by FDA. FDA would not approve a drug without a proprietary name.

A "lean" application as you describe appears to me to be a high risk regulatory strategy and not a good start to build a good relationship with FDA for a streamline review.  If I were your company, I would identify a proprietary name and let the "partner" submit a label or name change in the future. If the goal is approval then you need to meet all the requirements for acceptance by FDA for review.  Is your company ready to announce a refusal to file for this application? 

I would be interested in other perspectives,

Dar

-------------------------------------------
Darlene Rosario
VP Regulatory Affairs and Quality
Biothera
3388 Mike Collins Drive
Eagan, MN
United States
-------------------------------------------






Original Message:
Sent: 10-05-2012 11:23
From: Tom Namsavanh
Subject: Proprietary Name

Hello,

So, I've read a topic about "Hare or Tortoise" filing and was wondering if, as part of a "lean" submission, we can omit the Proprietary Name aspect of the submission package.
We are a small business that progress through partnerships. We haven't found a commercial partner for this product yet (that we intend to file a 505(b)(2) in Q2 2013), so performing a study on the appropriateness of a Proprietary Name is the big question since the potential might prefer another name (even this can be done as post-approval change).

Question: Is proprietary name approval required at the time of submission or can this be done post-approval but before commercialization?

Thank you.

Regards,

-------------------------------------------
Tom Namsavanh RAC
Manager, Regulatory Affairs and Compliance
Intelgenx Corp.
Saint-Laurent QC
Canada
-------------------------------------------

Dear Tom, 

to build on Darlene's message. My two cents: you should submit a proprietary name and have at least 5 back-up names. Without a name, there will be issue for your labeling approval, you get the INN name in your label, and/or it may delay the PDUFA date. Of note: it is not the Review Division but rather DMEPA and OSE who review the names for  medication errors (Look Alike Sound Alike rule, no USAN or INN stem, no dosage form, no fanciful). The best place to start is to use the concept paper issued by FDA (available on their web site -search word "concept paper") and apply the criteria delineated in the document to select the name(s) from a "pool" of names pre-vetted by legal. 

I do  not know at what stage you are but, if you are at pre-NDA phase , you can submit a name in your IND and get tentative acceptance.If not I would advise to submit the proposed proprietary name in your NDA with you proposed PI.The sooner the better. 
Do not mind submitting the assessment done by the consulting company-- this should be for your internal reference to guide your selection of the names. FDA do their own assessment.
Believe it or not the best names comes from the employees--you can have some fun and propose a contest (with a price).
Good Luck!

-------------------------------------------
Isabelle Lefebvre
Director
Bausch & Lomb
Chatham NJ
United States
-------------------------------------------






Original Message:
Sent: 10-07-2012 10:03
From: Darlene Rosario
Subject: Proprietary Name

Tom,

You always ask such interesting questions. I would hope that your company is planning or has already requested your pre-NDA or BLA meeting or scientific advise meeting with RA authorities as this is the appropriate place to have this strategic discussion. Since you mention a 505(b)(2) type submission, I am assuming a submission to FDA.

Submission of a "trade" name is typically included in your filing and could result in a refusal to file your application as part of the check list prior to review; that is, is the application complete such that FDA would accept it for review.  A proprietary name is important such that FDA can evaluate any conflicts with similar therapies and their trade names with a focus to avoid prescription errors. 

Most companies, typically have their name vetted by an organization that evaluates the name for potential conflicts with other products such that the name at the time of submission has a high probability of being accepted by FDA. FDA would not approve a drug without a proprietary name.

A "lean" application as you describe appears to me to be a high risk regulatory strategy and not a good start to build a good relationship with FDA for a streamline review.  If I were your company, I would identify a proprietary name and let the "partner" submit a label or name change in the future. If the goal is approval then you need to meet all the requirements for acceptance by FDA for review.  Is your company ready to announce a refusal to file for this application? 

I would be interested in other perspectives,

Dar

-------------------------------------------
Darlene Rosario
VP Regulatory Affairs and Quality
Biothera
3388 Mike Collins Drive
Eagan, MN
United States
-------------------------------------------






Original Message:
Sent: 10-05-2012 11:23
From: Tom Namsavanh
Subject: Proprietary Name

Hello,

So, I've read a topic about "Hare or Tortoise" filing and was wondering if, as part of a "lean" submission, we can omit the Proprietary Name aspect of the submission package.
We are a small business that progress through partnerships. We haven't found a commercial partner for this product yet (that we intend to file a 505(b)(2) in Q2 2013), so performing a study on the appropriateness of a Proprietary Name is the big question since the potential might prefer another name (even this can be done as post-approval change).

Question: Is proprietary name approval required at the time of submission or can this be done post-approval but before commercialization?

Thank you.

Regards,

-------------------------------------------
Tom Namsavanh RAC
Manager, Regulatory Affairs and Compliance
Intelgenx Corp.
Saint-Laurent QC
Canada
-------------------------------------------

@Darlene: As a matter of fact, our pre-NDA meeting will be held in a month, which gives me enough time to update my list of questions.

The mission I have been assigned is to take ALL measures (literally) necessary to not delay the "submission" (that I rephrased to "approval", a very important nuance). I will be on my way convincing upper management that it is in the company's best interest to have the best working relation with FDA.

@Isabelle: A contest seems fun. We'll see what our creativity is capable of ;) The preassessment will have to be outsourced (I've heard it may take as long as 3 months).

Warm regards,

-------------------------------------------
Tom Namsavanh RAC
Manager, Regulatory Affairs and Compliance
Intelgenx Corp.
Saint-Laurent QC
Canada
-------------------------------------------






Original Message:
Sent: 10-05-2012 11:23
From: Tom Namsavanh
Subject: Proprietary Name

Hello,

So, I've read a topic about "Hare or Tortoise" filing and was wondering if, as part of a "lean" submission, we can omit the Proprietary Name aspect of the submission package.
We are a small business that progress through partnerships. We haven't found a commercial partner for this product yet (that we intend to file a 505(b)(2) in Q2 2013), so performing a study on the appropriateness of a Proprietary Name is the big question since the potential might prefer another name (even this can be done as post-approval change).

Question: Is proprietary name approval required at the time of submission or can this be done post-approval but before commercialization?

Thank you.

Regards,

-------------------------------------------
Tom Namsavanh RAC
Manager, Regulatory Affairs and Compliance
Intelgenx Corp.
Saint-Laurent QC
Canada
-------------------------------------------

Tom, 

In your list of questions, you are not going to ask FDA whether you need to provide a Proprietary Name(s), are you?

To sound and act like or to be a real NDA applicant, you would want to propose several proposed Proprietary (Brand) Names for FDA to go through quality check (e.g., to avoid names for confusion).

In addition, you are not going to ask "what if questions" like "what if we get traded off down the road...."

FDA likes an application, which has been well prepared on points and addresses all applicable requirements.  That is how you make them happy and feel OK.  

Your efforts should be made to prepare for the very best application/materials.  You would definitely want to seek management's support rather than trying to convince the upper management for "what should be their best interest," which may give wrong connotation.

I suggest or recommend that you show your best efforts to your upper management and the very best NDA application will be submitted to FDA.  That is it.  

-------------------------------------------------------
Regulatory Doctor, Coach and Consultant
www.GlobalComplianceSeminar.Com
Riner VA
United States
------------------------------------------------------






Original Message:
Sent: 10-09-2012 11:58
From: Tom Namsavanh
Subject: Proprietary Name

@Darlene: As a matter of fact, our pre-NDA meeting will be held in a month, which gives me enough time to update my list of questions.

The mission I have been assigned is to take ALL measures (literally) necessary to not delay the "submission" (that I rephrased to "approval", a very important nuance). I will be on my way convincing upper management that it is in the company's best interest to have the best working relation with FDA.

@Isabelle: A contest seems fun. We'll see what our creativity is capable of ;) The preassessment will have to be outsourced (I've heard it may take as long as 3 months).

Warm regards,

-------------------------------------------
Tom Namsavanh RAC
Manager, Regulatory Affairs and Compliance
Intelgenx Corp.
Saint-Laurent QC
Canada
-------------------------------------------






Original Message:
Sent: 10-05-2012 11:23
From: Tom Namsavanh
Subject: Proprietary Name

Hello,

So, I've read a topic about "Hare or Tortoise" filing and was wondering if, as part of a "lean" submission, we can omit the Proprietary Name aspect of the submission package.
We are a small business that progress through partnerships. We haven't found a commercial partner for this product yet (that we intend to file a 505(b)(2) in Q2 2013), so performing a study on the appropriateness of a Proprietary Name is the big question since the potential might prefer another name (even this can be done as post-approval change).

Question: Is proprietary name approval required at the time of submission or can this be done post-approval but before commercialization?

Thank you.

Regards,

-------------------------------------------
Tom Namsavanh RAC
Manager, Regulatory Affairs and Compliance
Intelgenx Corp.
Saint-Laurent QC
Canada
-------------------------------------------

Dear Chang,

I appreciate the advice and will do so. I like contests anyway ;D

Regards,

-------------------------------------------
Tom Namsavanh RAC
Manager, Regulatory Affairs and Compliance
Intelgenx Corp.
Saint-Laurent QC
Canada
-------------------------------------------






Original Message:
Sent: 10-09-2012 13:45
From: Chang Lim
Subject: Proprietary Name

Tom, 

In your list of questions, you are not going to ask FDA whether you need to provide a Proprietary Name(s), are you?

To sound and act like or to be a real NDA applicant, you would want to propose several proposed Proprietary (Brand) Names for FDA to go through quality check (e.g., to avoid names for confusion).

In addition, you are not going to ask "what if questions" like "what if we get traded off down the road...."

FDA likes an application, which has been well prepared on points and addresses all applicable requirements.  That is how you make them happy and feel OK.  

Your efforts should be made to prepare for the very best application/materials.  You would definitely want to seek management's support rather than trying to convince the upper management for "what should be their best interest," which may give wrong connotation.

I suggest or recommend that you show your best efforts to your upper management and the very best NDA application will be submitted to FDA.  That is it.  

-------------------------------------------------------
Regulatory Doctor, Coach and Consultant
www.GlobalComplianceSeminar.Com
Riner VA
United States
------------------------------------------------------






Original Message:
Sent: 10-09-2012 11:58
From: Tom Namsavanh
Subject: Proprietary Name

@Darlene: As a matter of fact, our pre-NDA meeting will be held in a month, which gives me enough time to update my list of questions.

The mission I have been assigned is to take ALL measures (literally) necessary to not delay the "submission" (that I rephrased to "approval", a very important nuance). I will be on my way convincing upper management that it is in the company's best interest to have the best working relation with FDA.

@Isabelle: A contest seems fun. We'll see what our creativity is capable of ;) The preassessment will have to be outsourced (I've heard it may take as long as 3 months).

Warm regards,

-------------------------------------------
Tom Namsavanh RAC
Manager, Regulatory Affairs and Compliance
Intelgenx Corp.
Saint-Laurent QC
Canada
-------------------------------------------






Original Message:
Sent: 10-05-2012 11:23
From: Tom Namsavanh
Subject: Proprietary Name

Hello,

So, I've read a topic about "Hare or Tortoise" filing and was wondering if, as part of a "lean" submission, we can omit the Proprietary Name aspect of the submission package.
We are a small business that progress through partnerships. We haven't found a commercial partner for this product yet (that we intend to file a 505(b)(2) in Q2 2013), so performing a study on the appropriateness of a Proprietary Name is the big question since the potential might prefer another name (even this can be done as post-approval change).

Question: Is proprietary name approval required at the time of submission or can this be done post-approval but before commercialization?

Thank you.

Regards,

-------------------------------------------
Tom Namsavanh RAC
Manager, Regulatory Affairs and Compliance
Intelgenx Corp.
Saint-Laurent QC
Canada
-------------------------------------------