Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Dear Regulatory colleagues,

Long-time reader, first time poster here...

Question: Are HF studies required for drug product in vial?  What if product is intended for self-administration via subcutaneous injection iby the patient n the at-home setting?  Ancillary supplies such as syringe, needles, wipes, etc would be obtained by the patient separately (ie, these items would not be co-packaged with the drug product vials in a "kit" form).

Many thanks for your feedback and opinions.  I would be great if you could cite publicly accessible examples, guidelines, presentations, etc.

 

 

 

 

Dear Anonymous Member,

You will usually need to conduct Human Factors study if your product is self-injected. 

Here are 2 FDA Guidelines that may be of assistance to you:

https://www.fda.gov/downloads/MedicalDevices/.../UCM259760.pdf

https://www.fda.gov/downloads/regulatoryinformation/guidances/ucm484345.pdf

Sincerely yours, Suzanne

------------------------------
Suzanne Sensabaugh
President and Principal Consultant
Hartmannwillner LLC
Washington DC
United States
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Original Message:
Sent: 28-Aug-2017 22:23
From: Anonymous Member
Subject: HF studies for drug in vials?

This message was posted by a user wishing to remain anonymous

Dear Regulatory colleagues,

Long-time reader, first time poster here...

Question: Are HF studies required for drug product in vial?  What if product is intended for self-administration via subcutaneous injection iby the patient n the at-home setting?  Ancillary supplies such as syringe, needles, wipes, etc would be obtained by the patient separately (ie, these items would not be co-packaged with the drug product vials in a "kit" form).

Many thanks for your feedback and opinions.  I would be great if you could cite publicly accessible examples, guidelines, presentations, etc.