| 2004N-0337 - (Subpart D IRB Referral) Solicitation of Public Review and Comments on Research Protocol: Effects of a Single Dose of Dextroamphetamine in ADHD; A Functional Magnetic Resonance Study | |||||||||||||||||||||||
| FDA Comment Number : | EC1 | ||||||||||||||||||||||
| Submitter : | Dr. Ann Mayo | Date & Time: | 08/10/2004 02:08:10 | ||||||||||||||||||||
| Organization : | Kaiser Permanente | ||||||||||||||||||||||
| Health Professional | |||||||||||||||||||||||
| Category : | |||||||||||||||||||||||
| Issue Areas/Comments | |||||||||||||||||||||||
| GENERAL | |||||||||||||||||||||||
| GENERAL | |||||||||||||||||||||||
| Study is needed to generate important information. Written consents need to be clear for both parents and children. Assent documents need to be written at age appropriate reading levels. | |||||||||||||||||||||||