FDA Draft Guidance for Industry on Liposome Drug Products [Docket No. 02D-0337]From: pwatson@rdg.boehringer-ingelheim.com
Sent: Monday, November 25, 2002 5:40 PM
To: fdadockets@oc.fda.gov
Cc: coryj@cder.fda.gov
Subject: FDA Draft Guidance for Industry on Liposome Drug Products [Docke t No. 02D-0337]


Dear Sir or Madam:

Boehringer Ingelheim Pharmaceuticals, Inc. would like to provide the following comment on the subject draft Guidance for Industry:

Lines 112 - 116 give the impression that sterilizing filtration is the only sterilization procedure that may be used with a liposome drug product.  However, other procedures like heat sterilization may also be appropriate.  We suggest that Lines 112 - 113 of the guidance be modified to read as follows:

"For those liposome drug products sterilized by filtration, the chemical and physical complexity of liposomes can provide unique challenges to the sterilizing filtration process."

Sincerely,

Patricia Watson

Drug Regulatory Affairs

Boehringer Ingelheim Pharmaceuticals, Inc.

Ridgefield, CT

Phone:  203-791-6233

Fax:  203-791-6262