| 2006P-0360 | Determine that the discontinued formulation of Carbocaine Injection, 3b0supplied in 1.8 mL cartridge was not discontinued for safety and efficacy reasons | |||||||||||||||||||||||
| FDA Comment Number : | EC1 | |||||||||||||||||||||||
| Submitter : | Mr. Dave Lowe | Date & Time: | 08/31/2006 08:08:18 | |||||||||||||||||||||
| Organization : | Mr. Dave Lowe | |||||||||||||||||||||||
| Category : | Individual Consumer | |||||||||||||||||||||||
| Issue Areas/Comments | ||||||||||||||||||||||||
| GENERAL | ||||||||||||||||||||||||
| GENERAL | ||||||||||||||||||||||||
| I oppose the petition, safety and efficacy should be established outside the Federal Register. Executive Order 13258/12866 applies as well. | ||||||||||||||||||||||||