Regulatory Open Forum

Hi all,

My company needs to submit something through ESG to the FDA within the next ten days, but the primary regulatory contact will be out of the office for two weeks. Are there any additional regulations that need to be followed to contact the FDA without the primary regulatory contact?

Thanks for your help

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Christian Phipps
Cranbury NJ
United States
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I am personally not aware of a "delegation" regulation or policy from FDA for the primary regulatory contact, but typically if a contact is made from the same company this is usually acceptable.  It is only when an external contact such as a contractor or consultant is used that the company must provide in writing that they authorise FDA to communicate with this entity on their behalf.  It depends on what you are submitting in the ESG, but putting the title of the person and maybe if you can make a small note that the primary is not available - again as long as from the same company is usually accepted.

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Richard Vincins RAC
Vice President Regulatory Affairs
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Original Message:
Sent: 14-May-2018 10:46
From: Christian Phipps
Subject: Contacting the FDA without primary regulatory contact

Hi all,

My company needs to submit something through ESG to the FDA within the next ten days, but the primary regulatory contact will be out of the office for two weeks. Are there any additional regulations that need to be followed to contact the FDA without the primary regulatory contact?

Thanks for your help

------------------------------
Christian Phipps
Cranbury NJ
United States
------------------------------

​Our sponsor contact letters have a sentence that says "From time to time, COMPANY, may designate others to send or receive correspondence on xxxx's behalf".  That way, anyone can step in if needed.  I agree with others though if it's someone from the same company, it shouldn't be a problem.

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Beth Weinberg
Indianapolis IN
United States
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Original Message:
Sent: 15-May-2018 02:31
From: Richard Vincins
Subject: Contacting the FDA without primary regulatory contact

I am personally not aware of a "delegation" regulation or policy from FDA for the primary regulatory contact, but typically if a contact is made from the same company this is usually acceptable.  It is only when an external contact such as a contractor or consultant is used that the company must provide in writing that they authorise FDA to communicate with this entity on their behalf.  It depends on what you are submitting in the ESG, but putting the title of the person and maybe if you can make a small note that the primary is not available - again as long as from the same company is usually accepted.

------------------------------
Richard Vincins RAC
Vice President Regulatory Affairs

Original Message:
Sent: 14-May-2018 10:46
From: Christian Phipps
Subject: Contacting the FDA without primary regulatory contact

Hi all,

My company needs to submit something through ESG to the FDA within the next ten days, but the primary regulatory contact will be out of the office for two weeks. Are there any additional regulations that need to be followed to contact the FDA without the primary regulatory contact?

Thanks for your help

------------------------------
Christian Phipps
Cranbury NJ
United States
------------------------------

Dear Christian,

For submission purposes through the ESG, only those listed in your firm's "Letter of Non-Repudiation Agreement*" (Letter) are authorized to have access to the ESG.  Otherwise, the ESG will not accept the submission because it would fail to recognize the name if not listed in the Letter. 

*: The letter is the one filed (sent to the FDA) when you initially established the ESG account. 

The letter states as follows.

"this is to certify that [REGULATORY DOCTOR, ADDRESS] intends that electronic signatures executed by our employees, [List of employee names] are the legally binding equivalent of traditional hand-written signatures...."

D
Original Message:
Sent: 14-May-2018 10:46
From: Christian Phipps
Subject: Contacting the FDA without primary regulatory contact

Hi all,

My company needs to submit something through ESG to the FDA within the next ten days, but the primary regulatory contact will be out of the office for two weeks. Are there any additional regulations that need to be followed to contact the FDA without the primary regulatory contact?

Thanks for your help

------------------------------
Christian Phipps
Cranbury NJ
United States
------------------------------

The Non-Repudiation Letter is legally binding requirement in order to show the authenticity for use of the ESG. It is generally provided when company set-up their WebTrader account in order to use ESG.

Based on your time line concern I would  suggest that you can provide Non-Repudiation Letter with your name to the FDA at your earliest and try to contact help desk of ESG after mailing your letter and you can do your submission on your desired time line in absence of the authorized personnel.

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Gaurang Bhavsar, MS, RAC
Manager, R&D and RA
Sunrise Pharmaceutical, Inc.
Rahway, NJ 07065
USA
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Original Message:
Sent: 16-May-2018 11:59
From: David Lim
Subject: Contacting the FDA without primary regulatory contact

Dear Christian,

For submission purposes through the ESG, only those listed in your firm's "Letter of Non-Repudiation Agreement*" (Letter) are authorized to have access to the ESG.  Otherwise, the ESG will not accept the submission because it would fail to recognize the name if not listed in the Letter.

*: The letter is the one filed (sent to the FDA) when you initially established the ESG account.

The letter states as follows.

"this is to certify that [REGULATORY DOCTOR, ADDRESS] intends that electronic signatures executed by our employees, [List of employee names] are the legally binding equivalent of traditional hand-written signatures...."

D
Original Message:
Sent: 14-May-2018 10:46
From: Christian Phipps
Subject: Contacting the FDA without primary regulatory contact

Hi all,

My company needs to submit something through ESG to the FDA within the next ten days, but the primary regulatory contact will be out of the office for two weeks. Are there any additional regulations that need to be followed to contact the FDA without the primary regulatory contact?

Thanks for your help

------------------------------
Christian Phipps
Cranbury NJ
United States
------------------------------

Your company should have a designee that should enroll into ESG that ESG will recognized as another valid contact. Meaning this person or persons must've gone through the submissions process and ESG responded to them with the acknowledgement letters that verifies they can do a submmission. This takes a while so if your company only has one person, 10 days is most likely not enough time if you end up having Ack Letter issues.

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Clarisa Tate
VP, Product Development and Regulatory Affairs
Medical Devices Professional, RA/QA/Engineering
Bay Area, CA
USA
------------------------------

Original Message:
Sent: 14-May-2018 10:46
From: Christian Phipps
Subject: Contacting the FDA without primary regulatory contact

Hi all,

My company needs to submit something through ESG to the FDA within the next ten days, but the primary regulatory contact will be out of the office for two weeks. Are there any additional regulations that need to be followed to contact the FDA without the primary regulatory contact?

Thanks for your help

------------------------------
Christian Phipps
Cranbury NJ
United States
------------------------------