Regulatory Open Forum

Hello all,

I am looking for suggestions on how to handle a labeling change for a product that is packaged with a cap and a dropper is included to apply prescription oil to the ear.  This dropper has a cap and is consistently being used as the cap causing some issues (complaints).  We would like to create an instruction leaflet to notify the patient not to use the dropper as a cap but also provide proper use and cleaning of the dropper. 

Any suggestions on how to handle this and how to report this to FDA?  We are talking about submitting this in a CBE-0 with other labeling changes but we are not sure if will be received well by the patient. 

Thanks for your comments. 

-------------------------------------------
Alison Trado
Regulatory Affairs Manager
Hill Dermaceuticals, Inc.
Sanford FL
United States
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Alison,

If you are looking for some expertise in terms of preparing a user-friendly patient leaflet, I have had great experience working with Dr. Kala Paul at the Corvallis Group (kala.paul@thecorvallisgroup.com, (908) 273-2007, http://www.thecorvallisgroup.com).  Kala's expertise is in developing easy to understand labeling. 

If user testing for comprehension is needed (to confirm that patients can read, understand and follow instructions) she does that work as well.

Regards,
Mark

-------------------------------------------
Mark Ammann PharmD
President
Catalyst Regulatory Services, LLC
Dexter MI
United States
-------------------------------------------






Original Message:
Sent: 03-30-2012 13:34
From: Alison Trado
Subject: Labeling Change (Dropper for Ear)

Hello all,

I am looking for suggestions on how to handle a labeling change for a product that is packaged with a cap and a dropper is included to apply prescription oil to the ear.  This dropper has a cap and is consistently being used as the cap causing some issues (complaints).  We would like to create an instruction leaflet to notify the patient not to use the dropper as a cap but also provide proper use and cleaning of the dropper. 

Any suggestions on how to handle this and how to report this to FDA?  We are talking about submitting this in a CBE-0 with other labeling changes but we are not sure if will be received well by the patient. 

Thanks for your comments. 

-------------------------------------------
Alison Trado
Regulatory Affairs Manager
Hill Dermaceuticals, Inc.
Sanford FL
United States
-------------------------------------------

-------------------------------------------
Mark Ammann PharmD
President
Catalyst Regulatory Services, LLC
Dexter MI
United States
-------------------------------------------






Original Message:
Sent: 03-30-2012 13:34
From: Alison Trado
Subject: Labeling Change (Dropper for Ear)

Hello all,

I am looking for suggestions on how to handle a labeling change for a product that is packaged with a cap and a dropper is included to apply prescription oil to the ear.  This dropper has a cap and is consistently being used as the cap causing some issues (complaints).  We would like to create an instruction leaflet to notify the patient not to use the dropper as a cap but also provide proper use and cleaning of the dropper. 

Any suggestions on how to handle this and how to report this to FDA?  We are talking about submitting this in a CBE-0 with other labeling changes but we are not sure if will be received well by the patient. 

Thanks for your comments. 

-------------------------------------------
Alison Trado
Regulatory Affairs Manager
Hill Dermaceuticals, Inc.
Sanford FL
United States
-------------------------------------------