Docket Management
Docket: 01D-0582 - Draft Guidance for Industry on Available Therapy
Comment Number: EC -1

Accepted - Volume 1

Comment Record
Commentor Ms. Leah Ripper Date/Time 2002-04-04 17:28:24
Organization FDA/CDER
Category Other

Comments for FDA General
1. General Comments Line 166 speaks of approved labeling of regulated products. Which, if any, of the following would fall into this category: 1. The product is only marketed as a grandfathered (no NDA) drug product. 2. The product is marketed as a DESI-related product (no NDA). 3. The NDA was approved pre-l962 and the DESI review has not been completed for it (labeling includes the possibly effective box), e.g., Midrin.

EC -1