2005D-0122 Guidance for Industry on Exploratory IND Studies
FDA Comment Number : EC8
Submitter : Mrs. Gretchen Trout Date & Time: 07/15/2005 01:07:01
Organization : Schering-Plough
Category : Drug Industry
Issue Areas/Comments
Lines 227-228 require that "products intended for ophthalmic, inhalational, or parenteral administration, sterility must be ensured." Currently only aqueous inhalation products are required to be sterile, not all inhalation products. We request that the word "aqueous" be included with regard to inhalational products.