Docket Management
Docket: 00N-1269 - Labeling for Human Prescription Drug/Biologic Products
Comment Number: EC -23

Accepted - Volume 4

Comment Record
Commentor Mr. Howard C Anderson Jr. Date/Time 2001-06-04 15:36:08
Organization North Dakota Board of Pharmacy
Category Health Professional

Comments for FDA General
1. General Comments The proposed labeling changes appear to answer many of the complaints you have gathered about the product package inserts. As a pharmacist I made extensive use of the inserts and was able to find what I needed in them. The print was getting smaller, however.If 8 point is not large enough I will get stronger glasses. The placing of the boxed and any important warnings at the front is good as long as the and is adhered to. There is some danger that users may only consult the box,which is usually a warning added after the original marketing, and miss important product usage cautions in the main body of the insert. The index is certainly a great idea. I did notice that you mention Risks in three of the bullets you plan to add to the highlights. Be careful to be concise, eliminate clutter and make it appear that each item we read is important.

EC -23