Regulatory Open Forum

------------------------------
Marcy Sussman RAC
Director, Regulatory Affairs North America
Infirst Healthcare
Potomac MD
United States
------------------------------

Hi Marcy,

I'm not sure exactly what "clinical supplies" refers to (e.g. investigative product or something else?), but hopefully this link is of value to you: Who Must Register, List and Pay the Fee.

-Liz



------------------------------
Elizabeth Goldstein RAC
Regulatory Affairs Specialist
Medtronic Vascular
Santa Rosa CA
United States
------------------------------

Original Message:
Sent: 02-May-2017 05:59
From: Marcy Sussman
Subject: Foreign site establishment registration

Can anyone confirm whether a foreign site making clinical supplies for a study in the US needs to be registered prior to manufacturing and shipping the supplies?

------------------------------
Marcy Sussman RAC
Director, Regulatory Affairs North America
Infirst Healthcare
Potomac MD
United States
------------------------------

Elizabeth,

Thank you.  I wasn't clear in my original message that I'm talking about drugs.  The link you gave is for medical devices, and there it is crystal clear that for devices being investigated under an IDE the foreign site does not need to be registered.  I can't find a clear answer for drug products.  The supplies I'm talking about are for a study being done under an IND.

Marcy

------------------------------
Marcy Sussman RAC
Director, Regulatory Affairs North America
Infirst Healthcare
Potomac MD
United States
------------------------------

Original Message:
Sent: 02-May-2017 14:10
From: Elizabeth Goldstein
Subject: Foreign site establishment registration

Hi Marcy,

I'm not sure exactly what "clinical supplies" refers to (e.g. investigative product or something else?), but hopefully this link is of value to you: Who Must Register, List and Pay the Fee.

-Liz



------------------------------
Elizabeth Goldstein RAC
Regulatory Affairs Specialist
Medtronic Vascular
Santa Rosa CA
United States
------------------------------

Original Message:
Sent: 02-May-2017 05:59
From: Marcy Sussman
Subject: Foreign site establishment registration

Can anyone confirm whether a foreign site making clinical supplies for a study in the US needs to be registered prior to manufacturing and shipping the supplies?

------------------------------
Marcy Sussman RAC
Director, Regulatory Affairs North America
Infirst Healthcare
Potomac MD
United States
------------------------------

Hi Marcy,

21 CFR 207.40(b) exempts foreign sites from the registration requirement if the drug is "imported or offered for import under the investigational use provisions in part 312."

------------------------------
Cassandra McGurk
Sudbury MA
United States
------------------------------

Original Message:
Sent: 03-May-2017 06:43
From: Marcy Sussman
Subject: Foreign site establishment registration

Elizabeth,

Thank you.  I wasn't clear in my original message that I'm talking about drugs.  The link you gave is for medical devices, and there it is crystal clear that for devices being investigated under an IDE the foreign site does not need to be registered.  I can't find a clear answer for drug products.  The supplies I'm talking about are for a study being done under an IND.

Marcy

------------------------------
Marcy Sussman RAC
Director, Regulatory Affairs North America
Infirst Healthcare
Potomac MD
United States
------------------------------

Original Message:
Sent: 02-May-2017 14:10
From: Elizabeth Goldstein
Subject: Foreign site establishment registration

Hi Marcy,

I'm not sure exactly what "clinical supplies" refers to (e.g. investigative product or something else?), but hopefully this link is of value to you: Who Must Register, List and Pay the Fee.

-Liz



------------------------------
Elizabeth Goldstein RAC
Regulatory Affairs Specialist
Medtronic Vascular
Santa Rosa CA
United States
------------------------------

Original Message:
Sent: 02-May-2017 05:59
From: Marcy Sussman
Subject: Foreign site establishment registration

Can anyone confirm whether a foreign site making clinical supplies for a study in the US needs to be registered prior to manufacturing and shipping the supplies?

------------------------------
Marcy Sussman RAC
Director, Regulatory Affairs North America
Infirst Healthcare
Potomac MD
United States
------------------------------

Dear Marcy,

I agree with Cassandra. But please keep in mind that with certain exceptions any establishment engaged in the manufacture, repacking, relabeling of a drug product for commercial distribution will have to register with FDA. Do not hesitate to contact us if you require any further information.

------------------------------
Nitisha Pyndiah
Consultant
Hartmannwillner
Washington DC
United States
www.hartmannwillner.com
------------------------------

Original Message:
Sent: 03-May-2017 19:26
From: Cassandra McGurk
Subject: Foreign site establishment registration

Hi Marcy,

21 CFR 207.40(b) exempts foreign sites from the registration requirement if the drug is "imported or offered for import under the investigational use provisions in part 312."

------------------------------
Cassandra McGurk
Sudbury MA
United States
------------------------------

Original Message:
Sent: 03-May-2017 06:43
From: Marcy Sussman
Subject: Foreign site establishment registration

Elizabeth,

Thank you.  I wasn't clear in my original message that I'm talking about drugs.  The link you gave is for medical devices, and there it is crystal clear that for devices being investigated under an IDE the foreign site does not need to be registered.  I can't find a clear answer for drug products.  The supplies I'm talking about are for a study being done under an IND.

Marcy

------------------------------
Marcy Sussman RAC
Director, Regulatory Affairs North America
Infirst Healthcare
Potomac MD
United States
------------------------------

Original Message:
Sent: 02-May-2017 14:10
From: Elizabeth Goldstein
Subject: Foreign site establishment registration

Hi Marcy,

I'm not sure exactly what "clinical supplies" refers to (e.g. investigative product or something else?), but hopefully this link is of value to you: Who Must Register, List and Pay the Fee.

-Liz



------------------------------
Elizabeth Goldstein RAC
Regulatory Affairs Specialist
Medtronic Vascular
Santa Rosa CA
United States
------------------------------

Original Message:
Sent: 02-May-2017 05:59
From: Marcy Sussman
Subject: Foreign site establishment registration

Can anyone confirm whether a foreign site making clinical supplies for a study in the US needs to be registered prior to manufacturing and shipping the supplies?

------------------------------
Marcy Sussman RAC
Director, Regulatory Affairs North America
Infirst Healthcare
Potomac MD
United States
------------------------------

Thanks.  It looks though like 207.40 has been removed from the current CFR...

------------------------------
Marcy Sussman RAC
Director, Regulatory Affairs North America
Infirst Healthcare
Potomac MD
United States
------------------------------

Original Message:
Sent: 03-May-2017 19:26
From: Cassandra McGurk
Subject: Foreign site establishment registration

Hi Marcy,

21 CFR 207.40(b) exempts foreign sites from the registration requirement if the drug is "imported or offered for import under the investigational use provisions in part 312."

------------------------------
Cassandra McGurk
Sudbury MA
United States
------------------------------

Original Message:
Sent: 03-May-2017 06:43
From: Marcy Sussman
Subject: Foreign site establishment registration

Elizabeth,

Thank you.  I wasn't clear in my original message that I'm talking about drugs.  The link you gave is for medical devices, and there it is crystal clear that for devices being investigated under an IDE the foreign site does not need to be registered.  I can't find a clear answer for drug products.  The supplies I'm talking about are for a study being done under an IND.

Marcy

------------------------------
Marcy Sussman RAC
Director, Regulatory Affairs North America
Infirst Healthcare
Potomac MD
United States
------------------------------

Original Message:
Sent: 02-May-2017 14:10
From: Elizabeth Goldstein
Subject: Foreign site establishment registration

Hi Marcy,

I'm not sure exactly what "clinical supplies" refers to (e.g. investigative product or something else?), but hopefully this link is of value to you: Who Must Register, List and Pay the Fee.

-Liz



------------------------------
Elizabeth Goldstein RAC
Regulatory Affairs Specialist
Medtronic Vascular
Santa Rosa CA
United States
------------------------------

Original Message:
Sent: 02-May-2017 05:59
From: Marcy Sussman
Subject: Foreign site establishment registration

Can anyone confirm whether a foreign site making clinical supplies for a study in the US needs to be registered prior to manufacturing and shipping the supplies?

------------------------------
Marcy Sussman RAC
Director, Regulatory Affairs North America
Infirst Healthcare
Potomac MD
United States
------------------------------

There was a rule issues related to this in August '16 and then a correction in December but it left it unclear to me.  I can't attach them at the moment but will try to come back with links in a little bit.

------------------------------
Marcy Sussman RAC
Director, Regulatory Affairs North America
Infirst Healthcare
Potomac MD
United States
------------------------------

Original Message:
Sent: 05-May-2017 10:05
From: Marcy Sussman
Subject: Foreign site establishment registration

Thanks.  It looks though like 207.40 has been removed from the current CFR...

------------------------------
Marcy Sussman RAC
Director, Regulatory Affairs North America
Infirst Healthcare
Potomac MD
United States
------------------------------

Original Message:
Sent: 03-May-2017 19:26
From: Cassandra McGurk
Subject: Foreign site establishment registration

Hi Marcy,

21 CFR 207.40(b) exempts foreign sites from the registration requirement if the drug is "imported or offered for import under the investigational use provisions in part 312."

------------------------------
Cassandra McGurk
Sudbury MA
United States
------------------------------

Original Message:
Sent: 03-May-2017 06:43
From: Marcy Sussman
Subject: Foreign site establishment registration

Elizabeth,

Thank you.  I wasn't clear in my original message that I'm talking about drugs.  The link you gave is for medical devices, and there it is crystal clear that for devices being investigated under an IDE the foreign site does not need to be registered.  I can't find a clear answer for drug products.  The supplies I'm talking about are for a study being done under an IND.

Marcy

------------------------------
Marcy Sussman RAC
Director, Regulatory Affairs North America
Infirst Healthcare
Potomac MD
United States
------------------------------

Original Message:
Sent: 02-May-2017 14:10
From: Elizabeth Goldstein
Subject: Foreign site establishment registration

Hi Marcy,

I'm not sure exactly what "clinical supplies" refers to (e.g. investigative product or something else?), but hopefully this link is of value to you: Who Must Register, List and Pay the Fee.

-Liz



------------------------------
Elizabeth Goldstein RAC
Regulatory Affairs Specialist
Medtronic Vascular
Santa Rosa CA
United States
------------------------------

Original Message:
Sent: 02-May-2017 05:59
From: Marcy Sussman
Subject: Foreign site establishment registration

Can anyone confirm whether a foreign site making clinical supplies for a study in the US needs to be registered prior to manufacturing and shipping the supplies?

------------------------------
Marcy Sussman RAC
Director, Regulatory Affairs North America
Infirst Healthcare
Potomac MD
United States
------------------------------

Dear Marcy,

Please see 207.13(e) for the exceptions: manufacturers, repackers, relabelers, or salvagers who manufacture, repack, relabel, or salvage drugs solely for use in research, teaching, or chemical analysis and not for sale.

------------------------------
Nitisha Pyndiah PhD
Consultant
Hartmannwillner
Washington DC
United States
------------------------------

Original Message:
Sent: 05-May-2017 10:07
From: Marcy Sussman
Subject: Foreign site establishment registration

There was a rule issues related to this in August '16 and then a correction in December but it left it unclear to me.  I can't attach them at the moment but will try to come back with links in a little bit.

------------------------------
Marcy Sussman RAC
Director, Regulatory Affairs North America
Infirst Healthcare
Potomac MD
United States
------------------------------

Original Message:
Sent: 05-May-2017 10:05
From: Marcy Sussman
Subject: Foreign site establishment registration

Thanks.  It looks though like 207.40 has been removed from the current CFR...

------------------------------
Marcy Sussman RAC
Director, Regulatory Affairs North America
Infirst Healthcare
Potomac MD
United States
------------------------------

Original Message:
Sent: 03-May-2017 19:26
From: Cassandra McGurk
Subject: Foreign site establishment registration

Hi Marcy,

21 CFR 207.40(b) exempts foreign sites from the registration requirement if the drug is "imported or offered for import under the investigational use provisions in part 312."

------------------------------
Cassandra McGurk
Sudbury MA
United States
------------------------------

Original Message:
Sent: 03-May-2017 06:43
From: Marcy Sussman
Subject: Foreign site establishment registration

Elizabeth,

Thank you.  I wasn't clear in my original message that I'm talking about drugs.  The link you gave is for medical devices, and there it is crystal clear that for devices being investigated under an IDE the foreign site does not need to be registered.  I can't find a clear answer for drug products.  The supplies I'm talking about are for a study being done under an IND.

Marcy

------------------------------
Marcy Sussman RAC
Director, Regulatory Affairs North America
Infirst Healthcare
Potomac MD
United States
------------------------------

Original Message:
Sent: 02-May-2017 14:10
From: Elizabeth Goldstein
Subject: Foreign site establishment registration

Hi Marcy,

I'm not sure exactly what "clinical supplies" refers to (e.g. investigative product or something else?), but hopefully this link is of value to you: Who Must Register, List and Pay the Fee.

-Liz



------------------------------
Elizabeth Goldstein RAC
Regulatory Affairs Specialist
Medtronic Vascular
Santa Rosa CA
United States
------------------------------

Original Message:
Sent: 02-May-2017 05:59
From: Marcy Sussman
Subject: Foreign site establishment registration

Can anyone confirm whether a foreign site making clinical supplies for a study in the US needs to be registered prior to manufacturing and shipping the supplies?

------------------------------
Marcy Sussman RAC
Director, Regulatory Affairs North America
Infirst Healthcare
Potomac MD
United States
------------------------------