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Docket: 01D-0582 - Draft Guidance for Industry on Available Therapy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
Questions
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